Pramolan – composition, action, indications, contraindications and dosage

Proven content

Pramolan is a sedative and anxiolytic drug. The use of this preparation also improves mood. The active substance of Pramolan is opipramol dihydrochloride, which is a compound that belongs to monoamine reuptake inhibitors. What are the indications and contraindications for the use of Pramolan? How to properly dose this preparation? Can its use cause side effects?

Pramolan – general characteristics of the drug

Pramolan, the active substance of which is opipramol dihydrochloride, is a tricyclic antidepressant. This preparation is primarily anxiolytic and calming. Additionally, it makes it easier to fall asleep, reduces depression and improves well-being.

Pramolan is available in pharmacies upon presentation of a prescription and its price is non-refundable.

Pramolan are green, round, biconvex, film-coated tablets. The pack may contain 20, 28, 56 or 60 film-coated tablets. Not all of the above packages may be available in pharmacies.

The entity responsible for the production and distribution of Pramolan is Zakłady Farmaceutyczne POLPHARMA SA. Zakłady Farmaceutyczne Polpharma SA is a Polish pharmaceutical company based in Starogard Gdański. Ko

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Pramolan – composition and action of the drug

The active substance of Pramolan is opipramol dihydrochloride. Each Pramolan film-coated tablet contains 50 mg of opipramol dihydrochloride.

Opipramol is a medicine that belongs to the group of tricyclic antidepressants. It is distinguished among them by the fact that it does not inhibit the reuptake of norepinephrine and serotonin. Moreover, opipramol has low anticholinergic activity.

Opipramol has high affinity for sigma type 1 and type 2 receptors, and also blocks histamine H1 receptors. This drug binds less to serotonergic, dopaminergic and adrenergic receptors.

This substance has an anxiolytic, calming and mood-improving effect. It has a much weaker antidepressant effect. If the patient takes the drug in the evening, Pramolan will make you sleepy.

Opipramol is not addictive, but may impair the ability to drive and use machines.

Orally administered opipramol is absorbed quickly and completely. The biological half-life is 11 hours. This drug is metabolized in the liver. About 70% of the substance is excreted by the kidneys, including 5–9% unchanged. The remainder is excreted in the faeces.

In addition to the active substance, the drug also includes auxiliary substances. The tablet core contains: microcrystalline cellulose, povidone K 30, crospovidone, colloidal anhydrous silica and magnesium stearate. The ingredients of the tablet coating are: hypromellose, titanium dioxide (E171), lactose monohydrate, macrogol, triacetin, quinoline yellow, lake (E104), indigo carmine, lake (E132), sunset yellow, and lake (E110).

If you want to know more about opipramol, read on: Opipramol – an antidepressant drug

Pramolan – indications

Pramolan is primarily an antidepressant, sedative and anxiolytic. Indications for the use of Pramolan are generalized anxiety disorders and somatoform disorders, i.e., for example, physical discomfort unrelated to or insufficiently associated with organ disorders.

What is anxiety neurosis and how to deal with it? Read: Anxiety neurosis, or generalized anxiety disorder – causes, symptoms, treatment

Pramolan – contraindications

The drug Pramolan, despite its effectiveness in the treatment of anxiety disorders, cannot be used by every patient struggling with this type of ailments.

Contraindications to the use of Pramolan are:

1. hypersensitivity to the components of Pramolan and tricyclic antidepressants;
2. acute ethanol poisoning;
3. acute poisoning with drugs with a hypnotic, psychotropic and analgesic effect;
4. sharp stoppage of micturition;
5. delirium;
6. untreated narrow-angle glaucoma;
7. taking MAO inhibitors;
8. pre-existing higher degree AV block or supraventricular and ventricular conduction disturbances;
9. paralytic ileus;
10. prostatic hyperplasia with urine retention.

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Pramolan – precautions

Before and during the use of Pramolan, follow the precautions included in the package leaflet.

Particular care should be taken when taking Pramolan in the following cases:

1. if you have an enlarged prostate gland without retention of urine; 
2. if you have liver and kidney problems;  
3. if the patient has an increased predisposition to seizures (e.g. in case of brain damage of various origins, epilepsy, alcoholism);  
4. if you have insufficient blood supply to the brain (cerebral vascular insufficiency) and a history of heart damage, especially if you suffer from conduction disorders;  
5. if you have a blood cell production disorder; 
6. if you have a pre-existing first degree AV block; 
7. if you develop fever, flu-like infections or sore throat while taking this medicine;
8. if allergic skin reactions occur. 

It is also worth remembering that the drug should not be used after the expiry date stated on the box. The expiry date refers to the last day of that month. The drug should not be disposed of via wastewater or household waste. It’s best to ask your pharmacist how to dispose of medicines you no longer use.

What should you know about proper drug storage? Check: Medications that are stored wrongly are poisonous

Pramolan – dosage and method of use

Always use Pramolan exactly as described in the package leaflet or as directed by your doctor or pharmacist.

Pramolan film-coated tablets should be taken with or immediately after meals with water. As the effect of the drug is not immediate and the mood changes are gradual, the drug should be used systematically for at least 2 weeks. The recommended average duration of treatment is 1 to 2 months.

For adults, the recommended dose of Pramolan is 50 mg of opipramol dihydrochloride in the morning and at noon and 100 mg in the evening. It is worth recalling that a dose of 50 mg is one tablet of Pramolan. Depending on the progress of treatment, effectiveness and tolerance of the drug by the patient, the doctor may reduce the daily dose to one or two tablets or increase it to 6 tablets a day.

Use of Pramolan in children must always take place under close medical supervision. Children over 6 years of age are usually given 3 mg of opipramol dihydrochloride per kilogram body weight. A maximum of 100 mg of the drug can be administered, i.e. 2 tablets a day.

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Pramolan – misuse of the drug

Improper use of Pramolan is considered to be taking more than the recommended dose of the drug or missing the indicated dose during the day.

If you take more than the dose prescribed by your doctor, you may experience overdose symptoms, such as:

1. somnolence;
2. insomnia;
3. dizziness;
4. stimulation;
5. coma;
6. stupor;
7. transient states of confusion;
8. increasing anxiety;
9. ataxia (movement disorder);
10. seizures;
11. oliguria or anuria; 
12. fast heartbeat or slow heartbeat;
13. arrhythmia (irregular heartbeat);
14. atrioventricular block;
15. decrease in blood pressure;
16. shock;
17. difficulties with breathing;
18. rarely cardiac arrest.

If you miss a dose of Pramolan, take it as soon as possible. However, do not take a double dose to make up for a forgotten dose.

It is also worth mentioning about the side effects that may occur in the patient in the case of When you stop taking Pramolan. Only a doctor can decide to stop treatment. Discontinuation of this drug should be gradual by slowly lowering the dose. If you stop taking Pramolan suddenly, you might experience the following symptoms:

1. anxiety;
2. sweating;
3. nausea and vomiting;
4. sleep disturbance. 

If you have any further questions about the use of Pramolan, ask your doctor or pharmacist.

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Pramolan – side effects

Pramolan, like any other drug, may cause side effects in patients. It is important to report any suspected adverse reactions after authorization of the medicinal product so that the benefit / risk balance of the medicinal product can be monitored.

The frequency classification of adverse body reactions (ADRs) is based on the following principles: very common (≥1 / 10), common (≥1 / 100 to <1/10), uncommon (≥1 / 1 to <000/1), rare (≥ 100 / 1 to <10 / 000), very rare (<1 / 1), not known (cannot be estimated from the available data).

Bearing in mind the above rules, side effects of Pramolan can be indicated, which occur with different frequency.

Common side effects after taking Pramolan (affects less than 1 in 10 patients):

1. tiredness, dry mouth and nasal congestion (especially at the beginning of treatment);
2. hypotension and drops in blood pressure associated with changes in body position (especially at the beginning of treatment).

Uncommon side effects after taking Pramolan (affects less than 1 in 100 patients):

1. dizziness, sleepiness, urination disorder, accommodation disturbance, tremors, weight gain, feeling thirsty;
2. rapid heartbeat, palpitations;
3. constipation;
4. skin allergic reactions (rash, hives);
5. ejaculation failure, erectile dysfunction.

Rare side effects after taking Pramolan (occurs in less than 1 in 1 patients):

1. states of agitation, headache, paraesthesia (pricking, burning or tingling sensation in the limbs), especially in the elderly, states of confusion and delirium (especially associated with abrupt withdrawal or long-term use of high doses), agitation, sweating, sleep disturbances ;
2. cardiovascular collapse, conduction disturbances, worsening of existing heart failure;
3. nausea, vomiting, gastrointestinal disturbances, altered taste, paralytic intestinal obstruction (especially in the event of abrupt discontinuation of the drug or long-term treatment with high doses);
4. swelling; 
5. urinary retention;
6. mlekotok.

Very rare side effects after taking Pramolan (occurs in less than 1 in 10 patients):

1. cerebral seizures, abnormal coordination of movements (ataxia, dyskinesia), inability to sit still (akathisia), diseases of the peripheral nerves (polyneuropathy), sudden glaucoma, anxiety;
2. severe liver dysfunction, after long-term treatment jaundice and chronic liver damage;
3. hair loss.

Treatment with Pramolan may also change your blood picture and therefore your doctor may order blood tests. During treatment, the following may occur:

1. increase in serum liver enzymes (substances that give an indication of how the liver is working);
2. decrease in the number of white blood cells in the blood (leukopenia);
3. lack of granulocytes in the blood (agranulocytosis).

Are over-the-counter sedative medications available in pharmacies? How to choose the best preparation? Check: Sedative tablets without a prescription – composition, action. Which over-the-counter sedatives to choose?

Pramolan – interactions with other drugs

Before starting treatment with Pramolan, please inform your doctor or pharmacist about all the medicines you are taking or have taken recently. You should also inform what medications the patient plans to take in the near future.

It is especially important that the patient informs the doctor about the use of the following preparations:

1. neuroleptics (e.g., haloperidol, risperidone); 
2. sleeping pills (e.g. barbiturates);
3. sedatives (e.g. benzodiazepines);
4. tricyclic antidepressants;
5. drugs for the treatment of Parkinson’s disease;
6. anticonvulsants;
7. phenothiazines;
8. serotonin reuptake inhibitors (e.g., sertraline);
9. fluoxetine and fluvoxamine;
10. beta blockers (e.g. propranolol);
11. antiarrhythmic drugs;
12. drugs that affect the microsomal system of liver enzymes;
13. monoamine oxidase inhibitors (MAOIs) – MAO inhibitors should be discontinued at least 14 days before the planned intake of Pramolan.

It should also be remembered that alcohol in combination with opipramol may cause drowsiness.

Which drugs should never be combined with each other? Check: Dangerous interactions

Pramolan – food interactions

When using Pramolan, you should also take proper care of your diet. You should limit your fat intake while taking Pramolan, and above all: fatty meats, butter, lard or fast food products. High-fat meals increase the absorption of the drug, leading to the risk of side effects.

You should also avoid taking supplements containing St. John’s wort. St John’s wort lowers the amount of the drug in the blood.

Foods that are sources of nitrates should also be limited during treatment with opipramol. These are greenhouse vegetables sold in early spring, such as: lettuce, radishes, carrots, cucumbers, spinach, kohlrabi and cauliflower.

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Pramolan and pregnancy and breastfeeding

The use of any medications or dietary supplements during pregnancy requires consultation with the attending physician. If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking Pramolan.

It is allowed to use the drug during pregnancy. However, before starting the treatment, the benefits and risks of using the preparation should be carefully considered. Particular caution should be exercised in the case of the need to use the preparation in the first trimester of pregnancy.

However, while breastfeeding, it is recommended that breastfeeding is discontinued during treatment with Pramolan. The active substance of the drug, although in small amounts, passes into breast milk.

What is worth knowing about proper supplementation during pregnancy? Check: Conscious choices. Diet and supplementation in pregnancy

Pramolan — cena

Cena leku Pramolan may differ depending on the city in which the antibiotic will be purchased or the pharmacy chosen by the patient. The price of the product also depends on the number of tablets contained in the package:

1. a pack of Pramolan with 20 tablets costs about PLN 14-15;
2. a pack of Pramolan with 56 tablets costs about PLN 35-40;
3. A pack of Pramolan with 84 tablets costs about PLN 55-60.

How much money does the average Pole spend on treatment? Check: The Pole is not expected to see a doctor