Paraclim

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Medically reviewed

Marina Burgos

Last updated on 10/01/2026

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 Paraclim

Property Description
Active ingredient Tibolone
Form Tablet
Pharmacological class Selective Tissue Estrogenic Activity Regulator (STEARM)
Origin Synthetic steroid derivative

Paraclim: Definition, Composition, and Class

Paraclim is a prescription-only medicine defined by its single active ingredient, Tibolone. It is chemically a specialized synthetic steroid derivative, not a naturally occurring compound, and is supplied as a tablet intended for oral administration. The composition features Tibolone along with the necessary pharmaceutical excipients to form the compressed matrix. Paraclim is specifically positioned within the hormonal management category for postmenopausal women.

What Type of Agent is Paraclim?

Paraclim belongs to the highly specific pharmacological classification known as a Selective Tissue Estrogenic Activity Regulator (STEARM). This designation signifies that the drug is designed to modulate hormone activity in a site-specific, targeted manner, distinguishing it from conventional, non-selective hormone replacement methods. Tibolone is characterized as a steroidal agent with combined hormonal activities, which supports its use in addressing the hormonal consequences of menopause. This means the medicine works differently across various body parts, offering a specialized method of hormonal regulation.

Functional Profile of Tibolone

The overall general purpose of Paraclim is to modulate and stabilize the hormonal environment through its specific metabolic pathway. After oral administration, Tibolone is rapidly converted into three distinct active metabolites—3alpha-hydroxytibolone, 3beta-hydroxytibolone, and Delta^4-tibolone—each contributing to the drug's triple profile of hormonal activities. The activity of Tibolone includes combined estrogenic, progestogenic, and weak androgenic effects, offering a profile distinct from single-hormone treatments.

Regulatory References

  1. MedlinePlus: Hormone Replacement Therapy (HRT)

What side effects are possible with Paraclim?

Possible Side Effects and Safety Information: Paraclim

The safety profile of Paraclim (Tibolone) is officially structured by government regulatory agencies based on frequency and impact, defining the possible adverse reactions and associated risks. The reactions are categorized by the physiological systems affected, such as Reproductive system and breast disorders and Gastrointestinal disorders.


Official Adverse Reactions and Frequency

Adverse reactions are classified according to standard regulatory frequency categories derived from clinical trials:

  • Common Reactions: These are frequently reported effects and include vaginal discharge, endometrial thickening, postmenopausal haemorrhage, breast tenderness, weight increase, and pelvic pain.
  • Uncommon Reactions: These occur less frequently and may include oedema (swelling), abdominal discomfort, and acne.

Documented Serious Safety Risks

Regulatory documents formally link the use of Tibolone to an increased risk of specific serious conditions:

  • Vascular Events: An increased risk of stroke (predominantly ischaemic) is noted, with the risk specifically increasing from the first year of treatment, particularly in women over 60 years of age. An increased risk of Venous Thromboembolism (VTE), including Deep Vein Thrombosis (DVT) and Pulmonary Embolism (PE), is also documented.
  • Hormone-Sensitive Cancers: An increased risk of endometrial cancer in women with an intact uterus and an increased risk of breast cancer are reported in official labeling.

Key Safety Constraints

Use of Paraclim is strictly limited by formal contraindications stated in regulatory documentation. The medicine must not be used in individuals with severe hepatic impairment, active liver disease, a history of arterial or venous thromboembolic disease (such as prior stroke or DVT), undiagnosed abnormal genital bleeding, or a known history of breast cancer.

Overdose and Emergency Response

Overdose and when to seek help

The official regulatory profile for Paraclim (Tibolone) overdose indicates that the compound is generally associated with low acute toxicity. The documented clinical manifestations of an acute overdose are typically non-severe, confined primarily to the reproductive and gastrointestinal systems.

Documented presentations include vaginal bleeding and mild gastrointestinal symptoms, such as nausea, vomiting, or abdominal discomfort. Official regulatory documents do not formally highlight specific severe or life-threatening outcomes, reflecting the low acute risk of the compound. No population-specific considerations regarding increased overdose severity are explicitly documented.


Immediate Action and Management

It is officially mandated to seek immediate medical attention for any known or suspected overdose. This action is required as there is no specific antidote known or listed in the regulatory labeling for Tibolone. The defined approach to management in a clinical setting is symptomatic and supportive treatment.

A medical professional may determine the need for procedural interventions, such as gastric lavage, particularly if a large dose is confirmed to have been ingested within the initial two to three hours. Urgent medical consultation remains necessary if any manifestations are persistent or exhibit increased severity.

Therapeutic Uses of Paraclim

Paraclim (Tibolone) is primarily used for the management of oestrogen deficiency symptoms experienced by women after menopause and is considered relevant for managing risk associated with postmenopausal bone loss. It is applied across domains where additional symptomatic support is needed for the physical and psychological discomforts associated with the climacteric period. The therapeutic use of Paraclim is relevant for addressing symptoms that occur after menopause and for supporting bone health in high-risk women.

Managing Symptoms Related to Vasomotor and Systemic Imbalance

This domain covers symptoms related to systemic imbalance and psychological discomfort. Paraclim may help in managing the frequency and intensity of common hot flushes and night sweats, which are symptoms that may interfere with daily functioning and sleep quality. By addressing these symptom clusters, it may contribute to maintaining a sense of stability and supports patients during periods of heightened symptoms.


Addressing Symptoms Linked to Urogenital Discomfort

Paraclim is commonly used to help with symptoms related to vaginal atrophy and urogenital discomfort caused by oestrogen lack. This benefit may assist with symptoms related to inflammatory or irritative states, such as vaginal dryness and dyspareunia. Addressing these issues provides supportive relief that may assist with maintaining functional stability and supports general well-being during symptomatic phases.


Quick Fact: Support for Vasomotor Symptoms Paraclim is commonly used to help manage the intensity and frequency of hot flushes and night sweats, assisting patients in improving day-to-day comfort and supporting functional stability during symptomatic periods.

Eligibility and Restrictions for Use

Who Can and Cannot Use Paraclim

The eligibility for using Paraclim (Tibolone) is strictly defined by official regulatory labeling, reserving use for a specific patient population while listing absolute contraindications based on medical history and status.


Approved Population and Timing

Category Eligibility Rule
Eligible Population Women who are more than one year after the menopause (postmenopausal).
Timing Treatment must not begin until at least 12 months after the last natural menstrual bleed.

Absolute Contraindications

Use of Paraclim is strictly prohibited for individuals with:

  • A confirmed history of breast cancer or any oestrogen-dependent malignant tumours.
  • Active or past history of venous thromboembolism (VTE) or arterial thromboembolic disease (e.g., stroke, heart attack).
  • Acute liver disease or uncorrected abnormal liver function tests.
  • Undiagnosed vaginal bleeding or untreated endometrial hyperplasia.
  • Confirmed pregnancy or lactation (breastfeeding).

Conditional Use and Restrictions

Women over 60 years of age require careful assessment of stroke risk before use. Certain conditions, including hypertension, diabetes mellitus, and uterine fibroids, necessitate close medical supervision if Paraclim is used.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Official documentation identifies specific patterns of interaction between Paraclim (Tibolone) and certain co-administered medicinal products or substances. These interactions are classified based on their effect on drug concentrations or the activity of the interacting substance.


Pharmacokinetic and Metabolic Interactions

Co-administration with substances that are potent enzyme inducers can accelerate the metabolism of Tibolone. Government regulatory sources specify that strong CYP3A4 inducers, such as the anti-infective medicine Rifampicin and the anticonvulsants Carbamazepine and Phenytoin, cause a reduction in the plasma concentrations (exposure) of Tibolone's active metabolites. This effect may potentially lead to a reduced therapeutic benefit of Paraclim.

Separately, the herbal product St John's Wort (Hypericum perforatum), which is classified as an enzyme inducer, is also documented to potentially lower the effectiveness of Paraclim due to this mechanism.


Pharmacodynamic and Co-administered Drug Enhancement

Paraclim may cause an enhancement of the anticoagulant effect when co-administered with oral coumarin anticoagulants (e.g., Warfarin). This pharmacodynamic effect is documented in regulatory labeling and results in an increase in the International Normalized Ratio (INR) of the anticoagulant, which reflects greater activity of the co-administered drug.

No mandatory timing separation rules are explicitly documented, and official sources state that food intake does not alter the overall exposure of Tibolone to a clinically significant degree.

Mechanism of Action

How Paraclim Works: Mechanism of Action

Receptor Activation on Smooth Muscle

Paraclim's mechanism begins by acting as an agonist on the Bitter Taste Receptor (TAS2R14) found on the surface of airway smooth muscle cells. This targeted interaction utilizes a non-canonical signaling pathway, initiating a change in muscle tone through Gi-protein coupling.

Disruption of the Actin Cytoskeleton

Activation of TAS2R14 triggers an intracellular cascade involving the scaffolding protein Par3 and the subsequent inhibition of LIM kinase. This critical step maintains the activity of cofilin, a protein that actively severs and disassembles the F-actin cytoskeleton, a key component of cellular contractility.

Peripheral Smooth Muscle Relaxation

By destabilizing the structural components responsible for contraction, Paraclim causes peripheral smooth muscle relaxation in the airways. The resulting physiological effect is bronchodilation, an increase in the diameter of the air passages.

Dosage and Administration Information

How to Use Paraclim

Paraclim (Tibolone) is used according to specific instructions outlining the proper method, dose, and frequency of administration. This section details the high-level usage principles for the medication.


Official Usage Principles

Usage Entity Map Description
Route and Form Oral administration only, supplied as a tablet.
Standard Dosing The established therapeutic dose is 2.5 mg taken once daily.
Frequency Pattern Administered on a once daily schedule.

Administration Timing and Schedule

Paraclim is prescribed as a continuous, uninterrupted regimen for long-term use, without designated breaks or cycles. The tablet must be swallowed whole and should be taken at the same time each day to ensure consistent drug levels, irrespective of food intake. No specific dose adjustment is typically required for the elderly population.


Handling Missed Doses

Adherence to the daily schedule is maintained by a defined protocol for missed doses. If a scheduled dose is missed, it should be taken immediately only if less than 12 hours have elapsed since the usual administration time. If more than 12 hours have passed, the missed dose must be skipped, and the next dose should be taken at the regularly scheduled time. A double dose should never be taken to compensate for the omission.

Recent Clinical Evidence

Research evidence / Overview of Studies for Paraclim


Evidence for Relief of Vasomotor and General Climacteric Symptoms

Research has explored Paraclim in Randomized Controlled Trials (RCTs) against placebo, primarily examining outcomes related to systemic imbalance, such as hot flashes, night sweats, and changes in mood. These studies monitored the frequency of episodic symptoms and recorded patient-reported outcomes. The evidence contributes to understanding symptom patterns observed over defined time intervals, typically short-term to medium-term. Long-term effects are not fully established, and evidence quality varies when comparing results against other conventional hormone treatments.


Evidence for Bone Health and Fracture Risk

Paraclim was evaluated in large-scale RCTs and systematic reviews relevant in evidence describing conditions associated with bone loss. Research examined changes in Bone Mineral Density (BMD) and the incidence of vertebral and non-vertebral fractures. Data on fracture incidence came from a large trial focused on older women with established bone conditions. However, this study was stopped prematurely, meaning follow-up durations were limited. Consequently, the full scope of long-term outcomes are not fully established regarding the incidence of fractures.


Evidence for Urogenital Symptoms and Scientific Gaps

RCTs have explored Paraclim in settings relevant to outcomes linked to inflammatory or irritative states, such as vaginal dryness and pain during intercourse (dyspareunia), alongside sexual function scales. Research describes patterns observed over short- to intermediate-term follow-up. Sample sizes were modest in many trials focused on this domain, leading to limited information for long-term outcomes.

Additionally, the existing research highlights scientific uncertainty: comparative evidence is lacking for many specific head-to-head assessments against all alternative hormone treatments, and data for certain patient groups remain insufficient outside of the specific populations studied.

Frequently Asked Questions (FAQ)

Common questions about Paraclim (FAQ)


Q: What is the main medical condition Paraclim is approved to treat?

A: The drug is officially indicated for the symptomatic treatment of hot flushes and associated sweating resulting from natural or surgical menopause.

It is also approved for the prevention of post-menopausal osteoporosis (bone thinning), according to regulatory documentation.


Q: Does Paraclim cure the underlying condition, or does it primarily manage symptoms?

A: Paraclim is officially indicated for the symptomatic treatment of hot flushes and associated conditions.

Its function is described as modulating the hormonal environment, indicating its regulatory role is to manage symptoms rather than provide a cure for the underlying postmenopausal state.


Q: Why might a doctor prescribe Paraclim instead of a different drug for the same condition?

A: Official documentation describes Paraclim as having a selective tissue-specific profile.

This includes combined hormonal activities—estrogenic, progestogenic, and weak androgenic activity—which is noted to be a distinguishing combination compared to non-selective methods. This unique profile may influence the decision to use the drug.


Q: How does Paraclim compare to the generic version, if one exists?

A: The active ingredient in Paraclim is Tibolone.

Official documents confirm the drug's composition features Tibolone along with the necessary pharmaceutical excipients used to form the tablet.


Q: How long does it typically take for a person to notice the effects of Paraclim?

A: Clinical studies have observed improvement in typical menopausal symptoms over specified timeframes.

Evidence of symptom improvement has been noted in assessments conducted after a period of short-term use.


Q: What happens to the body if a patient stops taking Paraclim suddenly?

A: Because Paraclim is prescribed for the symptomatic relief of menopausal symptoms, the potential return of those symptoms is described in the drug's profile after the treatment is discontinued.

This is a common pharmacological outcome when symptomatic treatments are stopped.


Q: What are the official restrictions for Paraclim use in children or teenagers?

A: Official documentation strictly restricts the use of Paraclim to the treatment of postmenopausal women.

This primary indication makes the medicine inappropriate for use by children or teenagers.


Q: Can a patient with a known kidney issue still use Paraclim?

A: While Paraclim is not generally contraindicated based on a known kidney issue, official warnings note that conditions such as kidney disease may necessitate close medical supervision.

Eligibility is defined by the treating physician based on these regulatory constraints.


Q: What is the general guideline for Paraclim use in older adult patients?

A: For older patients, no specific dose adjustment is typically required based on age alone.

However, official guidelines specify that women over 60 years of age require careful medical assessment, particularly concerning the increased risk of stroke associated with the medicine.


Q: Can Paraclim cause noticeable changes in body weight or appetite?

A: Official regulatory documents list weight increase as a common adverse reaction observed during treatment.

However, specific changes in appetite are not detailed within the categorized frequency of reported adverse reactions.


Q: Is it possible for Paraclim to affect a person's mood or behavior?

A: Official information indicates that mental or mood changes are potential side effects that are noted in regulatory information.

Additionally, clinical evidence has examined the drug's activity in relation to emotional states, including depressive mood and anxiety.


Q: Are there specific warnings about how Paraclim might affect sleep patterns?

A: Official research evidence has specifically examined the drug's effect on sleep problems and night sweats.

Clinical research has noted improvement in these symptoms, which are commonly associated with menopause.


Q: Does Paraclim interact with common over-the-counter pain relievers like ibuprofen or acetaminophen?

A: Official documents note that other drugs in the Nonsteroidal Anti-Inflammatory Drug (NSAID) class may have interaction considerations, such as the potential enhancement of thrombogenic effects.

No specific interaction with acetaminophen is detailed in the official warnings.


Q: What does official guidance say about drinking alcohol while taking Paraclim?

A: Authoritative patient information states that there is no known contraindication to drinking alcohol while taking Paraclim.

However, official guidance includes limiting alcohol intake to potentially help manage hot flushes and may improve sleep.


Q: Are there any specific foods, drinks, or supplements that should be avoided with Paraclim?

A: Official documents specifically warn that the herbal product St John's Wort may reduce the effectiveness of Paraclim.

Beyond this specific warning, regulatory information notes that food intake generally does not significantly change the amount of the drug the body absorbs.


Q: How quickly does Paraclim leave the body after the last dose is taken?

A: Pharmacokinetic data in official documents indicates that the elimination half-life of Paraclim and its active metabolites is less than 2 days.

The half-life describes the time required for the amount of drug in the body to be reduced by half.


Q: What safety information is available about taking Paraclim in case of an accidental overdose?

A: Official patient information states that acute toxicity studies suggest no toxic effects are to be expected from an accidental overdose.

However, if serious symptoms such as passing out or trouble breathing occur, regulatory guidance recommends seeking emergency medical assistance.


Q: Can Paraclim affect a person's ability to operate machinery or drive a car?

A: Official regulatory documents specifically state that Paraclim will not usually affect a person's ability to drive or operate machinery.


Q: Are there specific warnings about Paraclim and exposure to sunlight?

A: Official patient information contains warnings that the drug may cause melasma, which presents as blotchy, dark areas on the skin.

Since sunlight may worsen this effect, the regulatory guidance includes limiting sun exposure while using the medicine.


Q: Are there specific symptoms that warrant calling a doctor immediately while on Paraclim?

A: Regulatory documents specify serious conditions that require immediate medical attention.

These include possible signs of a blood clot, such as painful swelling of the legs or sudden chest pain, or symptoms of a stroke, like a sudden severe headache or trouble speaking.

How should Paraclim be stored and disposed of?

Paraclim's official regulatory labeling specifies strict conditions for storage, handling, and disposal to maintain the stability of the medicine.

Storage Requirements

Condition Requirement Restriction
Temperature Store below 30 C Do not refrigerate or freeze
Environment Protect from light and moisture Avoid excessive heat
Packaging Store in the original package Must be kept out of the sight and reach of children

These storage conditions are required to protect the tablets from environmental degradation over the product’s 3-year shelf-life. Keeping the medicine in the original packaging helps maintain protection from light and moisture.

Disposal Instructions

Unused or expired Paraclim must be disposed of according to official procedures. It should not be thrown away via wastewater or general household waste, as this is restricted to prevent the active substance from entering the environment. The product must be returned to a pharmacist or disposed of via a local, regulated drug take-back scheme.

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

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