Cidolut Nor

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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 Cidolut Nor

What is Cidolut Nor? (Hormonal Agent)

Cidolut Nor is a prescription-only hormonal medication that contains the synthetic progestin Norethisterone as its single active pharmaceutical ingredient (API). This preparation is formulated as a sterile, oily solution for intramuscular injection, distinguishing it as a depot product designed for prolonged, sustained release of the medication within the body.


Quick Facts

Property Description
Active Ingredient Norethisterone
Form Sterile, Oily Solution
Route Intramuscular Injection (Depot)
Pharmacological Class Progestogen (19-Nortestosterone derivative)
Origin Synthetic Hormone Derivative

Pharmacological Context

Cidolut Nor is classified pharmacologically as a progestogen, a group of synthetic compounds that mimic the activity of the naturally occurring female hormone progesterone, which is essential for regulating the menstrual cycle. The active component, Norethisterone, is specifically a second-generation progestin, known for its high potency and stability.

This medication is distinguished by its injectable, non-oral route of administration. The oily vehicle ensures slow absorption from the muscle tissue, maintaining stable hormonal levels for an extended period following a single dose. Norethisterone exerts its influence by binding to and activating progesterone receptors in target tissues, such as the uterus, creating a predictable and controlled hormonal environment within the patient's system.

What side effects are possible with Cidolut Nor?

Possible Side Effects and Safety Information

This section outlines the adverse reactions and safety constraints officially documented for Norethisterone Enanthate (the active ingredient in Cidolut Nor) in government regulatory documents, grouped by frequency and organ system.

Frequency-Classified Adverse Reactions

The following frequency categories are based on regulatory summaries, such as the Summary of Product Characteristics (SmPC) for the injectable formulation:

Frequency Classification Documented Adverse Reactions (Selected)
Very Common (≥ 1 in 10) Uterine/Vaginal bleeding, spotting, short-lasting amenorrhoea (absence of periods).
Common (≥ 1 in 100 to < 1 in 10) Headache, dizziness, nausea, weight increase, injection site reactions, local skin reactions, and skin disorder.
Uncommon (≥ 1 in 1,000 to < 1 in 100) Depressed mood, breast discomfort, bloating.

Serious Adverse Reactions and Safety Constraints

Regulatory documentation highlights specific, clinically significant risks and limitations associated with the use of this medication:

  • Serious Adverse Reactions: The official label documents the risk of thromboembolic disorders (such as deep vein thrombosis, pulmonary embolism, stroke, and myocardial infarction) and the rare occurrence of benign or malignant liver tumours.

  • Population-Specific Constraints: The medication is formally contraindicated (must not be used) in several contexts, including known or suspected pregnancy and the presence of severe hepatic impairment or liver tumours. Use is also restricted in cases of undiagnosed abnormal uterine bleeding until malignancy is ruled out.

  • Time-Related Safety Patterns: Changes in the menstrual pattern (e.g., spotting) are noted as likely to alter during the entire exposure period. The risk of thrombosis is also mentioned as potentially being increased, particularly in the first year of use of hormonal contraceptives.

The official safety profile is designed to clearly define these documented risks and limitations, separating common expected effects from serious, rare adverse reactions.

Overdose and Emergency Response

Overdose and when to seek help

The official regulatory profile for an overdose of Cidolut Nor, which contains the progestin Norethisterone, defines the expected manifestations and required emergency actions based on government prescribing information. The overdose is generally characterized by low acute toxicity and the absence of a specific antidote.


Documented Overdose Presentations

Overdose may manifest primarily as symptoms associated with hormonal excess. The officially documented clinical presentations include nausea, vomiting, breast enlargement, and the later occurrence of vaginal bleeding.

As no specific antidote is known for Norethisterone, treatment is officially mandated to be symptomatic and supportive to manage the manifestations.


When to Seek Immediate Medical Help

Immediate medical attention is required for any suspected overdose event. Specifically, official guidance states that emergency services must be contacted immediately if the affected individual has collapsed, experiences a seizure, has trouble breathing, or cannot be awakened. Prompt reporting of suspected over-exposure ensures proper supportive care is initiated.

Therapeutic Uses of Cidolut Nor

What Cidolut Nor Treats: Main Uses and Benefits

Cidolut Nor is a progestogen medication generally applied across domains where additional symptomatic support is needed for gynecological contexts. The medicine is considered relevant in clinical settings that involve acute or unstable symptom patterns related to the menstrual cycle.

This medication is commonly used to help manage conditions associated with the female reproductive system, including irregular periods, heavy bleeding, and the discomfort associated with endometriosis. It is also applicable for short-term menstruation postponement.

Therapeutic Focus and Relief

This medication is used in situations involving certain distressing symptoms and helps address symptom clusters that may become intense or disruptive. For patients experiencing heightened discomfort, it offers symptomatic relief that supports patients during episodes of heightened discomfort.

“The use of this medication is to provide supportive relief when symptoms interfere with routine activities.”


Quick Fact: Relief for Disruptive Symptoms

Cidolut Nor is commonly used across conditions presenting with episodic or fluctuating manifestations, playing a role in managing symptoms that create noticeable physiological strain.

Eligibility and Restrictions for Use

Official Eligibility and Contraindications for Cidolut Nor

Cidolut Nor (norethisterone) is subject to strict eligibility rules based on regulatory guidelines, primarily classifying use as either Contraindicated or requiring Special Consideration.


Classification Populations and Conditions
Contraindicated (Use Prohibited) Pregnancy or suspected pregnancy; Lactation (breastfeeding); History of or current venous or arterial thromboembolic events (e.g., deep vein thrombosis, pulmonary embolism, myocardial infarction); History of migraine with focal neurological symptoms; Diabetes mellitus with vascular complications; Presence or history of liver tumours (benign or malignant) or severe hepatic disease until liver function normalizes; Known or suspected sex hormone-dependent malignancies; Hypersensitivity to the active substance or excipients; Undiagnosed genital bleeding; Concomitant use with certain anti-viral medications (ombitasvir/paritaprevir/ritonavir and dasabuvir).
Use Not Recommended Nursing mothers (can decrease milk production); Patients with certain rare hereditary problems (e.g., galactose intolerance or glucose-galactose malabsorption); Women with a high risk of thrombosis.
Special Consideration/Supervision Patients with a history of epilepsy, migraine, asthma, or cardiac/renal dysfunction (due to potential for fluid retention); Individuals with diabetes (requires strict medical supervision); Patients with a positive personal or strong family history of thromboembolism (requires specialist consultation before use).

Age-Related Eligibility: The official labeling does not establish specific age-related restrictions, but eligibility is determined by the presence or absence of the listed contraindications and risk factors. Use in women must exclude pregnancy.

This medicine is primarily contraindicated in patients with a history of blood clotting disorders, severe liver disease, or hormone-dependent cancers. Its use is limited in individuals with certain chronic conditions, demanding careful evaluation before starting treatment.

What should I know about interactions with other medicines?

Cidolut Nor Interactions with other medicines and products

The interaction profile for Norethisterone, the active ingredient in Cidolut Nor, is primarily structured around pharmacokinetic changes and specific additive pharmacodynamic effects documented in official regulatory labeling.

Interactions Reducing Norethisterone Exposure

Co-administration with enzyme-inducing agents is officially documented to increase the metabolism of Norethisterone, resulting in a reduction of its plasma concentrations. This interaction pattern is associated with specific substances, including the antiseizure medications phenytoin and carbamazepine, the antibiotic rifampin, and the immunosuppressant Aminoglutethimide. Certain antiviral medications, such as Ritonavir and Nelfinavir, are also noted to exhibit enzyme-inducing properties that accelerate steroid metabolism. Additionally, the herbal product St John's wort (Hypericum perforatum) may similarly induce metabolism and reduce exposure.

Other Documented Interaction Types

Norethisterone has been reported in regulatory documents to cause an increase in the plasma concentrations of the immunosuppressant Cyclosporin. A separate pharmacodynamic interaction is noted with other drugs that cause fluid retention, such as Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) and vasodilators, due to a potential additive effect on this specific symptom. Furthermore, progestogens are documented to influence the results of certain clinical tests, including those used to evaluate thyroid function and blood coagulation. No mandatory timing separation rules are explicitly documented for co-administration.

Mechanism of Action

Cidolut Nor contains norethisterone, a synthetic progestin that functions as an agonist of the progesterone receptor (PR). Upon binding to the cytosolic PR, the activated receptor complex translocates to the nucleus where it interacts with specific DNA sequences, modulating the transcription of target genes.

This molecular activity yields several downstream system-level physiological consequences. The compound suppresses the pulsatile release of Gonadotropin-Releasing Hormone (GnRH) from the hypothalamus, which, in turn, blunts the pre-ovulatory surge of Luteinizing Hormone (LH) from the pituitary gland. Furthermore, norethisterone induces morphological changes in the endometrium, leading to atrophy and reduced glandular proliferation. It also causes the cervical mucus to become more viscous and cell-rich, which mechanically impedes cellular passage.

Dosage and Administration Information

Administration Method

Cidolut Nor tablets are intended for oral use. The tablets should be swallowed whole with a drink of water. They can be taken regardless of food intake, though maintaining a consistent routine may help in remembering to take the medication.

Timing and Consistency

For the medication to be effective, it is important to take the tablets at approximately the same time each day. The specific schedule and duration of use are determined by the underlying condition being addressed.

Duration of Use

The length of the course depends on the reason for the prescription. In some instances, the tablets are taken during specific days of the menstrual cycle, while in other cases, continuous daily administration may be required. The course should be completed as prescribed even if symptoms improve early in the process.

Missed Doses

Maintaining a regular schedule is necessary to ensure the stability of hormone levels in the body. If a dose is not taken at the scheduled time, it should be addressed according to the general principles of hormone replacement or supplementation therapy to maintain efficacy and minimize the risk of breakthrough bleeding.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Cidolut Nor

This section provides a summary of the clinical studies that have explored the use of Norethisterone, the active component in Cidolut Nor, focusing on what was studied for each recognized indication and what patterns were observed in the study populations.


Evidence for Management of Heavy Bleeding and Irregular Cycles

Research exploring Norethisterone for conditions characterized by fluctuating or episodic manifestations of abnormal bleeding was studied for in various trials, including Randomized Controlled Trials (RCTs). These investigations monitored outcomes related to systemic or functional imbalance, such as measuring changes in blood loss, the frequency of bleeding episodes, and the achievement of amenorrhea (absence of menstrual bleeding) in women of reproductive age.

Studies specifically involving the long-acting injectable Norethisterone Enanthate (NET-EN) formulation reported findings that indicate participants were observed in relation to variable bleeding patterns; some trials described the occurrence of irregular bleeding or amenorrhea in study populations. This means the research highlights changes measured during the study period related to cycle stability, but evidence is limited regarding its dedicated use for acute, non-contraceptive cycle regulation compared to the oral form.

Evidence for Symptoms Associated with Endometriosis

Research exploring Norethisterone for symptoms associated with endometriosis was studied for in comparative trials, often examining the oral form of the medication. These studies included RCTs and reports that examined outcomes related to physical discomfort such as changes in pain intensity using visual analogue scales (VAS) and measurements of changes in the volume of ovarian endometriomas over treatment periods lasting six months or longer.

Studies monitored outcomes related to physical discomfort over defined time intervals. Research describes measurements related to endometriotic tissue size, and findings describe patterns observed in the studies where participants reported changes in pain intensity over the treatment duration. However, comparative evidence is lacking for the specific long-acting depot injection formulation when measured directly against other dedicated endometriosis therapies.

Key Limitations and Areas of Uncertainty

A key limitation found in the research base for Cidolut Nor is the variability in formulations used across clinical trials. While the symptomatic uses (heavy bleeding, endometriosis) are well-studied for the Norethisterone oral formulation (Norethisterone Acetate/NETA), the injectable depot form (NET-EN) is overwhelmingly characterized by evidence related to fertility control and long-acting hormonal suppression. Consequently, the specific outcomes and observed patterns of the depot injection when used exclusively for the short-term symptomatic indications are not as comprehensively characterized by dedicated, large-scale clinical trials as the oral regimens.

Key Studies & References

  1. Treatment of Heavy and/or Prolonged Menstrual Bleeding Without Organic Cause (NCT02943655) - ClinicalTrials.gov
  2. Norethisterone Dosing Guidelines for Menstrual Cycle Delay (Example of regulatory/guideline information on postponement)

Frequently Asked Questions (FAQ)

Common questions about Cidolut Nor (FAQ)


Q: Is it safe long-term?

Official product information addresses considerations for long-term use by summarizing risks observed in clinical trials, such as serious adverse reactions. These include reactions like acute pancreatitis, complications related to diabetic retinopathy, acute kidney injury, and gallbladder disease. Furthermore, regulatory documents note the risk of thyroid C-cell tumors identified in rodent studies.


Q: Can children 2 years old use it?

According to the regulatory information, the safety and effectiveness of this medication have not been established in patients under 18 years of age. The medication is not currently authorized for use in children aged 2 years.


Q: Should I stop taking it if I become pregnant?

Regulatory information indicates that there are limited data on using this medication during pregnancy. The official prescribing information indicates that women planning to become pregnant should consider discontinuing the medication at least 2 months before conception. This suggestion relates to the long duration the drug stays in the body.

How should Cidolut Nor be stored and disposed of?

How to Store and Dispose of Cidolut Nor?

This section details the official storage, handling, and disposal requirements for Cidolut Nor (Norethisterone) as defined in government regulatory documents.

Requirement Official Statement
Storage Temperature Do not store above 25 C (Controlled Room Temperature).
Packaging Store in the original package.
Shelf-Life Five years (for the finished 5mg tablet product).
Handling No special requirements; keep in original container.
Disposal Dispose of contents/container to a hazardous or special waste collection point in accordance with local regulations.
Environmental Rule Avoid release to the environment.

Cidolut Nor must be protected by maintaining a temperature at or below 25 C and keeping the medicine sealed in its original container to preserve its documented shelf-life. The active substance is classified for special waste collection, requiring disposal at a designated hazardous waste point rather than through general waste or flushing to prevent environmental contamination.

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

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