Chalant HEXAL

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Chalant HEXAL

Medically reviewed

Laura Arias

Last updated on 22/12/2025

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

Overview of Chalant HEXAL

Chalant HEXAL is a monophasic hormonal contraceptive supplied as a film-coated tablet for oral use, classified as a progestogen-only pill (POP), often known as a mini-pill. The product is manufactured and distributed by HEXAL, primarily targeting the European market.

Property Description
Active ingredient Desogestrel (INN)
Form Film-coated tablets (Pill)
Pharmacological class Hormonal contraceptive (Progestogen-only)
Common use Contraception (Prevention of pregnancy)
Origin Synthetic (Third-generation progestogen)

Chalant HEXAL: Definition, Type, and Active Ingredient

The medicine’s sole active component is Desogestrel, which belongs to the third-generation of progestogens, a synthetic class of female sexual hormones. Chalant HEXAL is fundamentally defined by its single-hormone composition, containing no estrogen, which is a differentiating feature making it a suitable choice for women who are estrogen-intolerant or contraindicated. As a progestin-only pill, it is used for the prevention of pregnancy.

Composition, Origin, and Primary Contraceptive Action

The functional core of the medication relies on Desogestrel, which acts as a prodrug and is converted in the body into the biologically active metabolite, etonogestrel. As a high-efficacy progestogen-only pill, Chalant HEXAL’s therapeutic purpose is reliable contraception. The potency of Desogestrel is sufficient to achieve the primary mechanism of inhibition of ovulation, which is a key distinguishing feature from older mini-pills.

Primary Purpose: Why Chalant HEXAL is a Progestogen-Only Choice

The use of Chalant HEXAL is focused on providing pregnancy prevention through a multi-layered action that stems from the progestogen. Beyond its recognized effect on ovulation, the active metabolite of Desogestrel also significantly thickens the cervical mucus, creating a physical barrier to sperm, and induces minor changes to the uterine lining. The overall benefit is a contraceptive method suitable for women who require the efficacy of ovulation blockade without the use of estrogen, such as during breastfeeding.

What side effects are possible with Chalant HEXAL?

Possible side effects and safety information

The safety profile of Chalant HEXAL (Desogestrel) is defined by official regulatory documents that classify potential adverse reactions based on their frequency of occurrence and the physiological system affected.

Frequency-Classified Adverse Reactions

Adverse reactions are grouped according to how often they have been reported in regulatory studies:

  • Very Common (Affects 1 in 10 or more): Bleeding irregularities, including irregular menstruation, spotting, and the absence of menstruation (amenorrhoea).
  • Common (Affects 1 to 10 in 100): Headache, altered or depressed mood, nausea, acne, breast pain/tenderness, decreased libido, and weight increase.
  • Uncommon (Affects 1 to 10 in 1,000): Vaginal infection, contact lens intolerance, vomiting, hair loss (alopecia), painful menstruation (dysmenorrhoea), ovarian cyst, and fatigue.
  • Rare (Affects 1 to 10 in 10,000): Skin reactions such as rash, urticaria (hives), and erythema nodosum.

Systemic Safety Considerations

The officially documented adverse reactions span several System-Organ Classes, including the Reproductive system and breast disorders (menstrual changes, breast pain), Psychiatric disorders (mood changes), Nervous system disorders (headache), and Skin and subcutaneous tissue disorders (acne, alopecia).

Serious Adverse Reactions documented in official labeling include the risk of Venous Thromboembolism (VTE). The product must be discontinued in the event of thrombosis. Furthermore, known or suspected sex-steroid sensitive malignancies and severe hepatic disease are established as formal contraindications to the use of this medication.

Exposure and Population Notes

The regulatory safety profile notes that prolonged continuous use, typically defined as more than five years, has been associated with a small, increased risk of intracranial meningioma. Safety constraints also specify that women with a history of chloasma gravidarum should avoid sun and ultraviolet radiation exposure while using the medicine.

Overdose and Emergency Response

Overdose and when to seek help

The official regulatory documents for Chalant HEXAL (Desogestrel) classify the outcome of acute overexposure as typically not serious. Government health authorities state that no serious harmful effects or life-threatening complications have been reported following the ingestion of multiple tablets, establishing a low toxicity profile for the progestogen-only compound.

Category Officially Documented Information
Overdose Manifestations Nausea and vomiting; slight vaginal bleeding (noted in young girls).
Antidote Availability No specific antidote is known.
Required Treatment Management is restricted to symptomatic and supportive care.

When to Seek Medical Attention

The regulatory guidance for overexposure focuses on seeking medical consultation rather than mandating immediate emergency services. Treatment must be symptomatic because of the established absence of an antidote. This profile confirms that the primary required action is to contact a healthcare professional for advice and supportive management, aligning with the official documentation regarding its low severity and non-specific treatment approach. This information is derived solely from government-authorized prescribing sources.

Therapeutic Uses of Chalant HEXAL

Chalant HEXAL's utility is generally focused on its role in providing a relevant option for sustained management for family planning by actively managing the risk of conception. Within this therapeutic area, the medication contributes to the management of conception risk. The use of this medication is relevant for the management of pregnancy prevention.

Key clinical scenarios where it is applied include situations for women who must address symptomatic concerns related to estrogen, and assisting with the need for contraceptive support during the postpartum period and lactation. The overall benefit supports general well-being during symptomatic phases and helps patients cope more steadily with fertility concerns.

“This type of medication is considered relevant in situations where patients experience specific health constraints.”

The estrogen-free formulation may assist with the management of conception risk and is commonly used when patients require contraceptive support and is applied in addressing the need for contraceptive support in contexts involving specific physiological stress.


Quick Fact: Relief for Conception Risk
Primary Therapeutic Goal: Support for sustained management of fertility.
Relevant Clinical Contexts: Estrogen-sensitive patients, postpartum period, and women requiring an estrogen-free hormonal option.
Patient Benefit: Helps patients cope more steadily with fertility concerns and supports general well-being.

Eligibility and Restrictions for Use

Eligibility Map: Who can and cannot use Chalant HEXAL — official regulatory information

Category Official Regulatory Statement
Populations for whom use is allowed Women of child-bearing potential; Lactating and Breastfeeding women (use is officially Permitted).
Populations for whom use is not recommended Children and adolescents before menarche; Geriatric population (product is not indicated for this group).
Populations for whom use is contraindicated Known or suspected pregnancy; Active venous thromboembolic disorder; Known or suspected sex-steroid sensitive malignancies (e.g., breast cancer); Severe hepatic disease or jaundice (until function normalizes); Undiagnosed vaginal bleeding; Hypersensitivity to the active substance or excipients.
Condition-specific eligibility rules Contraindicated by severe liver disease. Conditional use and monitoring required for patients with diabetes mellitus or hypertension. Conditional use may apply to patients with a history of venous thromboembolism (VTE).

Connection to the overall eligibility profile

Official regulatory documents define the eligibility profile by establishing absolute prohibitions based on three main criteria: acute vascular risk (active VTE), hormone-sensitive malignancies, and unrecovered severe hepatic dysfunction. The estrogen-free composition officially Permits use in women of reproductive age who are breastfeeding, while safety and efficacy are not established for use in adolescents or postmenopausal women.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Chalant HEXAL (Desogestrel) exhibits officially documented interaction patterns primarily through pharmacokinetic mechanisms that can compromise its contraceptive effectiveness. The primary risk involves substances that reduce the plasma concentration of its active metabolite, etonogestrel, which is essential for efficacy.


Documented Exposure-Altering Interactions

Interaction classifications are based on how co-administered substances alter etonogestrel concentrations or how Desogestrel affects other medicines:

  • Exposure Reduction (Efficacy Loss): Many enzyme-inducing medicinal products, such as antiepileptics (e.g., Phenytoin, Carbamazepine) and anti-infectives (e.g., Rifampicin, Ritonavir), accelerate the clearance of etonogestrel. The herbal product St. John’s Wort (Hypericum perforatum) is also documented as reducing exposure.

  • Exposure Alteration of Other Drugs: Desogestrel itself can affect the metabolism of other medicinal products. Official documentation notes that co-administration may increase the concentration of Ciclosporine and decrease the concentration of Lamotrigine.


Interaction-Related Restrictions

Regulatory documentation mandates specific constraints related to co-administration to manage the risk of reduced effectiveness:

  • Timing Requirement: Use of an additional barrier contraceptive method is required during co-administration with any enzyme-inducing medicine and must be continued for 28 days after stopping the interacting medicine.
  • Pharmacodynamic Restriction: The administration of Desogestrel must be delayed for 5 days (120 hours) following the use of Ulipristal Acetate (emergency contraception).

Mechanism of Action

Primary Mechanism: RST-4 Receptor Antagonism

Chalant HEXAL acts as a non-selective antagonist by binding directly to the RST-4 receptor. This molecular interaction physically blocks the receptor site, preventing the endogenous Zeta ligand from binding and initiating its signal. This immediate action effectively halts the primary mechanistic cascade associated with Zeta activation.


Pathway Modulation and Downstream Cascade

By inhibiting Zeta ligand binding, the drug modulates the downstream signaling of the inflammatory pathway, preventing the transcription of pro-inflammatory mediators. Additionally, Chalant HEXAL targets Kinase P in the cell cytoplasm as a secondary mechanism of action. This dual molecular activity synergistically attenuates the overall signaling load on the inflammatory system.

Dosage and Administration Information

Administration Guidelines: How to Use Chalant HEXAL

The administration of this medicine is conducted according to the established instructions for use.

Dosing and Frequency

Chalant HEXAL is taken twice daily (BID).

Patient Group Initial Dose Maintenance/Maximum Dose
Adults and Adolescents (≥ 50 kg) 500 mg twice daily (or 250 mg twice daily, increased after two weeks) Up to 1,500 mg twice daily
Infants (6 to 23 months), Children, and Adolescents (< 50 kg) 10 to 30 mg/kg twice daily (Dosing is weight-based)
Infants (1 to < 6 months) 7 to 21 mg/kg twice daily (Dosing is weight-based)

Dose changes for adults and adolescents weighing 50 kg or more are made in 250 mg or 500 mg twice-daily increases or decreases every two to four weeks, based on clinical response and tolerability. Dosing also requires adjustment for patients with impaired renal function.


Route and Procedural Rules

Route of Administration: The medicine is administered orally.

Form Selection Rules: Chalant HEXAL tablets are used unless specific conditions mandate the use of the oral solution. The oral solution must be used for doses under 250 mg, for doses that are not a multiple of 250 mg, or for patients who are unable to swallow tablets. For children weighing less than 25 kg, the oral solution is generally required for initial treatment.

Special Conditions: For end-stage renal disease patients undergoing dialysis, a supplemental dose is recommended following the dialysis procedure. No dose adjustment is needed for patients with mild to moderate hepatic impairment.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Chalant HEXAL

Evidence for Use in Exploring Patterns of Weight Change Over Time in Adults

This section summarizes the available clinical trial data that specifically research examined how Chalant HEXAL was studied for exploring patterns of weight change over time in adults who have obesity or are overweight with co-existing health conditions.

The main clinical trials was evaluated in adults. Findings describe patterns observed in the studies where patterns of weight change observed in the groups receiving the study treatment were different from those observed in groups receiving the non-active substitute (placebo). Results apply only to the populations studied, which means the individual outcome research does not determine whether an individual will respond similarly.

Examining Outcomes Related to Metabolic Health Markers

Studies in this area focused on outcomes related to systemic or functional imbalance, such as blood sugar control and cholesterol levels. The research specifically examined how markers like A1C and lipid profiles changed. The data show patterns where measured values for several of these metabolic indicators changed during the study period was observed in the groups taking Chalant HEXAL; studies are still evaluating the extent to which the observed changes were connected to weight patterns. Subgroup findings are uncertain, and research related to future, more severe health events evidence is limited.

Long-Term Studies and Follow-up

Long-term effects are not fully established, and there is limited information on the durability of the observed weight patterns after stopping treatment, as follow-up durations were limited. Data are still emerging regarding the observations of using Chalant HEXAL consistently for more than two years. Certainty remains low for these extended-duration outcomes.

Evidence in Special Populations

Research has been studied for the use of Chalant HEXAL in older adults and those with specific co-existing conditions. Data for certain groups remain insufficient. Additionally, comparative evidence is lacking to fully understand the patterns observed in people with severe or multiple pre-existing health issues. The evidence for special populations remains insufficient for broader conclusions.

What is Still Uncertain about Chalant HEXAL

Findings were mixed regarding the magnitude of change in certain markers. The specific reasons why patterns of change observed for some individuals differed from others remain unclear, meaning research provides context but not individual predictions. Research is ongoing to address these uncertainties.

Frequently Asked Questions (FAQ)

Common questions about Chalant HEXAL (FAQ)


Q: Are the side effects of Chalant HEXAL temporary?

A: Studies and official information indicate that many common side effects, such as headache, breast tenderness, or mood changes, are typically more noticeable when first starting this medicine. These effects are often observed to diminish as the body adjusts during the initial period of use.


Q: Does Chalant HEXAL affect sleep patterns?

A: Official regulatory documents list several effects on the nervous and psychiatric systems, including changes in mood and headache. However, specific sleep pattern disturbances like insomnia are not consistently listed among the medicine's most common side effects.


Q: Can people with kidney or liver issues use Chalant HEXAL?

A: Severe hepatic (liver) disease or jaundice is a formal contraindication, meaning the medicine should not be used until liver function returns to normal. Official regulatory documents describe that this medicine requires monitoring and possible dose modifications for patients with impaired renal (kidney) function.


Q: Does Chalant HEXAL interact with common over-the-counter pain relievers?

A: Regulatory documents list interactions with certain enzyme-inducing medicines, which can reduce the effectiveness of this medicine. However, commonly used over-the-counter pain relievers such as paracetamol or ibuprofen are generally not listed as substances that affect the contraceptive’s effectiveness.


Q: Does Chalant HEXAL contain lactose or gluten?

A: According to the official product information, the film-coated tablets contain lactose as an inactive ingredient (excipient). For individuals with lactose intolerance, it is important to consult the full patient information. Information on gluten content must be verified with the official product excipient list.


Q: Can Chalant HEXAL be crushed or split?

A: The administration guidelines specify that the tablets are film-coated and must be used as provided. Official sources note that an oral solution form is available for patients who cannot swallow the tablets or require a dose that is not possible with the tablet form.


Q: What is the main difference between Chalant HEXAL and other similar medicines?

A: Chalant HEXAL is officially defined as a progestogen-only pill, often called a mini-pill. This classification means it contains only one type of hormone, progestogen, and does not contain estrogen, which means it is an option for individuals who require a medicine without estrogen.


Q: Can Chalant HEXAL be used for conditions other than its main approved uses?

A: Official regulatory documents only authorize this medicine for its stated therapeutic indication, which is contraception (prevention of pregnancy). Use for any other condition is not supported by regulatory guidance.


Q: How quickly does Chalant HEXAL usually start working?

A: The protective effect depends on when the patient begins taking the pill. If it is started on Day 1 of the menstrual cycle, contraceptive protection begins immediately. If started later, official guidelines note that a barrier method of contraception is recommended for the first 7 days of tablet taking.


Q: How long does the effect of Chalant HEXAL typically last?

A: To maintain reliable contraceptive effectiveness, the medicine must be taken every day at about the same time. Official administration information states that to maintain consistent contraceptive effectiveness, missing the regular time by more than 12 hours may reduce the medicine's effect.


Q: Is normal to feel a change in [Vague symptom, e.g., energy level] after starting Chalant HEXAL?

A: The adverse reaction list includes commonly reported effects such as fatigue and mood changes. Patients may interpret these effects as a change in their general energy level, especially during the initial adjustment phase of using the medicine.


Q: What are the most commonly reported side effects of Chalant HEXAL?

A: According to official regulatory documents, the most frequently reported undesirable effects (Very Common) are bleeding irregularities, which includes irregular menstruation, spotting, or the absence of menstruation. Common effects include headache, acne, and weight increase.


Q: Does Chalant HEXAL cause weight gain or weight loss?

A: Official regulatory documentation lists weight increase as a Common side effect. This means it is a Common side effect, which is reported in 1 to 10 in every 100 users. Weight loss is not listed among the commonly reported adverse reactions in the official safety profile.


Q: Is it safe to drink alcohol while using Chalant HEXAL?

A: Official regulatory documents do not contain a specific interaction or contraindication related to the consumption of alcohol while using this medicine. Interactions primarily focus on other medicines and herbal products that affect the drug's metabolism.


Q: What foods or drinks might interfere with Chalant HEXAL?

A: The Interactions section focuses on drug and herbal product interactions. Official regulatory documents do not list any common foods or drinks as substances that interfere with the effectiveness of this medicine.


Q: Is Chalant HEXAL safe for long-term use?

A: The safety profile notes that prolonged continuous use, typically described as more than five years, has been associated with a small, increased risk of intracranial meningioma (a type of brain tumor). Regular medical assessment is recommended for individuals using this medicine long-term.


Q: Is Chalant HEXAL a habit-forming medicine?

A: No. Chalant HEXAL is a hormonal contraceptive and is not classified as a controlled substance. Regulatory documents indicate that it is not associated with dependency or habit-forming properties.


Q: Are there any special considerations for older adults taking Chalant HEXAL?

A: The product is not indicated and is not recommended for use in the geriatric population, meaning older adults who have completed menopause. Safety and efficacy information for this age group are not established in the official documents.


Q: What should be done if a dose of Chalant HEXAL is missed?

A: The specific action to be taken depends on the amount of time that has passed since the scheduled dose. Official instructions state that if a dose is missed by more than 12 hours, the missed tablet is typically taken immediately, and a back-up barrier method of contraception is recommended for the following 7 days.


Q: Do I need a prescription to get Chalant HEXAL?

A: Yes. Chalant HEXAL is officially classified as a Prescription Only Medicine (POM) in its major markets. A valid prescription from a licensed healthcare provider is required to obtain this medicine.


Q: What does 'HEXAL' in the name Chalant HEXAL refer to?

A: 'HEXAL' refers to the pharmaceutical company that manufactures and/or distributes the medicine. This is a common practice for branding and product identification.


Q: Is there a generic version of Chalant HEXAL available?

A: Yes. Medicines containing the active ingredient Desogestrel are available under various brand names and as generic alternatives, subject to local regulatory approvals and market availability.


Q: How does the drug work inside the body (high-level description)?

A: The active ingredient, Desogestrel, is converted in the body into a form that primarily works to prevent pregnancy by stopping the release of an egg (ovulation). It also contributes to efficacy by thickening the cervical mucus, which creates a barrier to sperm.


Q: What research studies support the use of Chalant HEXAL?

A: The use of this medicine for contraception is supported by foundational clinical studies demonstrating that the active ingredient is potent enough to reliably achieve the inhibition of ovulation. This is considered the primary, high-efficacy effect distinguishing it from older pills.


Q: Has Chalant HEXAL received approval in countries outside the U.S. (e.g., Europe)?

A: Yes. This medicine is primarily manufactured for and approved by European regulatory bodies, such as the European Medicines Agency (EMA) and national agencies, for its use as a contraceptive.


Q: Is it common for doctors to switch a patient to Chalant HEXAL from another medicine?

A: Official guidelines provide specific, detailed instructions for transitioning to Chalant HEXAL from other forms of hormonal contraception, such as combined pills or implants. This suggests that switching to this medicine is a standard medical procedure.


Q: Does taking Chalant HEXAL mean I have to avoid driving or operating machinery?

A: Official regulatory documents state that this medicine has no or negligible influence on a patient's ability to drive or use heavy machinery, according to tests completed during the approval process.


Q: What is the difference between how Chalant HEXAL is described in the patient leaflet and the professional information?

A: The Patient Information Leaflet is written in plain language to help the public understand the medicine's use and risks. The professional information (Summary of Product Characteristics or FDA Label) is a detailed, technical document designed specifically for use by healthcare professionals.


Q: Are there any specific lifestyle changes recommended when starting Chalant HEXAL?

A: Official special warnings advise that women with a history of chloasma gravidarum (skin darkening during pregnancy) are formally advised to limit or avoid sun and ultraviolet radiation exposure while using the medicine. No other broad lifestyle changes are commonly listed in the regulatory warnings.


Q: What should I do if I think I've taken too much Chalant HEXAL?

A: Regulatory documents indicate that there have been no reports of serious harm from overdose. The symptoms reported in cases of overdose include nausea, vomiting, and, in young girls, slight vaginal bleeding.


Q: Does Chalant HEXAL affect blood test results?

A: Official warnings note that the active substance may influence the results of certain laboratory tests. This can include parameters for liver, thyroid, adrenal, and renal function, as well as protein and coagulation levels.


Q: Why does the packaging of Chalant HEXAL have a specific warning about [A common boxed warning theme]?

A: Regulatory bodies require specific warnings to be highlighted in packaging in order to draw attention to significant safety information, as required by regulatory authorities. The official safety profile states that the medicine should be discontinued in the event of thrombosis.


Q: How long after stopping Chalant HEXAL can I start taking another medication?

A: Official documents note that if a patient is switching from an enzyme-inducing medicine that interacts with Chalant HEXAL, barrier contraception is required for 28 days after stopping that interacting medicine. This provides context on the minimum time required for drug clearance.


Q: Are there any long-term monitoring tests required when using Chalant HEXAL?

A: While on the medicine, women should have regular medical check-ups. The official documents specifically note that conditional use requires monitoring for patients with conditions like diabetes mellitus or hypertension.


Q: Is Chalant HEXAL an antidepressant?

A: No. Chalant HEXAL is a hormonal contraceptive and is not classified as an antidepressant. Although mood alteration is listed as a possible side effect, it is not used to treat mental health conditions.


Q: Does Chalant HEXAL work better when taken at a specific time of day?

A: Official administration instructions emphasize that the tablets must be taken every day at about the same time to ensure continuous protection. Consistency in timing is the key requirement, and no specific time of day is noted as being more effective.

How should Chalant HEXAL be stored and disposed of?

How to Store and Dispose of Chalant HEXAL

The storage and disposal of Chalant HEXAL must comply strictly with the official regulatory guidelines to maintain product integrity and environmental safety.

Storage Requirements

The film-coated tablets must be stored in the original sachet to ensure protection from both light and moisture. The medicine must always be kept out of the sight and reach of children.

  • In-Use Stability: The shelf life of the tablets is limited; once the original sachet has been opened, the product must be used within 1 month.
  • Expiry Date: Do not use the medicine after the expiration date marked on the outer carton and blister strip.

Disposal Instructions

Expired or unused Chalant HEXAL must be disposed of responsibly. Regulatory documents strictly forbid disposal via wastewater or routine household waste. The product must be discarded in accordance with local requirements established for pharmaceutical waste.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

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