Drotamax

Patient Information Leaflet User Information

Drotamax, 80 mg, tablets

Drotaverine hydrochloride

Read the contents of the leaflet carefully before taking the medicine, as it contains important information for the patient.

This medicine should always be taken exactly as described in the patient information leaflet or as advised by a doctor or pharmacist.

• You should keep this leaflet, so you can read it again if you need to. If you need advice or additional information, you should contact a pharmacist. If you experience any side effects, including any possible side effects not listed in the leaflet, you should tell your doctor or pharmacist. See section 4. If you do not feel better or feel worse after 7 days, you should contact your doctor.

Table of Contents of the Leaflet

• 1.
• 2.
• 3.
• 4.
• 5.
• 6. What Drotamax is and what it is used for. Important information before taking Drotamax How to take Drotamax Possible side effects. How to store Drotamax Contents of the pack and other information.

1. What Drotamax is and what it is used for.

Drotamax is a spasmolytic medicine used to treat:

• smooth muscle spasm conditions associated with biliary tract diseases: gallstones, bile duct stones, cholecystitis, pericholecystitis, cholangitis, and papillitis; smooth muscle spasm conditions associated with urological diseases: kidney stones, ureteral stones, pyelonephritis, cystitis, and painful urination.

Drotamax may be used as an adjunctive treatment for:

• gastrointestinal spasm conditions: gastric and duodenal ulcers, gastritis, gastric spasms, enteritis, and irritable bowel syndrome with spastic constipation or intestinal bloating;
• gynecological conditions: dysmenorrhea.

In the event of no improvement and in the event of worsening symptoms, you should consult a doctor.

2. Important information before taking Drotamax

When not to take Drotamax:

Warnings and precautions

Caution should be exercised when taking drotaverine in patients with hypotension.

Drotamax and other medicines

You should tell your doctor or pharmacist about all medicines you are taking, or have recently taken, and about any medicines you plan to take.
Taking drotaverine with levodopa (a medicine used for Parkinson's disease) may weaken the effect of levodopa, which may cause increased muscle stiffness and tremors.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, you should consult your doctor or pharmacist before taking this medicine.
Pregnancy
Drotaverine passes through the placenta.
This medicine should not be taken during labor.
Breastfeeding
This medicine is not recommended during breastfeeding, due to the lack of appropriate study results.

Driving and using machines

Drotamax, when taken in usual doses, usually does not affect the ability to drive or operate machines. If you experience dizziness after taking this medicine, you should not perform potentially hazardous activities, such as driving or operating machines.

Drotamax contains lactose.

If you have been diagnosed with an intolerance to some sugars, you should contact your doctor before taking this medicine.

3. How to take Drotamax

This medicine should always be taken exactly as described in the patient information leaflet or as advised by a doctor or pharmacist. If you are unsure, you should contact your doctor or pharmacist.

Adults:

• 1 tablet 2 or 3 times a day

Use in children and adolescents

No clinical trials have been conducted on the use of drotaverine in children.
If the medicine needs to be used, children over 12 years old should take 1 tablet 1 or 2 times a day. The maximum daily dose for children is 160 mg, which is 2 tablets.
Without consulting a doctor, the medicine should not be taken for more than 7 days.

Taking a higher dose of Drotamax than recommended

If you take one more tablet than recommended, it usually does not cause any adverse effects.
If you take more than the recommended dose of the medicine, you should contact your doctor immediately.

Missing a dose of Drotamax

You should not take a double dose to make up for a missed dose.
If you have any further doubts about taking this medicine, you should contact your doctor or pharmacist.

4. Possible side effects.

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Rare (occurring in 1 to 10 out of 10,000 patients):

Headache, dizziness, nausea, palpitations, insomnia, constipation, hypotension, and allergic reactions (edema, urticaria, rash, pruritus).

Reporting side effects

If you experience any side effects, including any possible side effects not listed in the leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products Al. Jerozolimskie 181C, 02-222 Warsaw Tel.: +48 22 49 21 301 Fax: +48 22 49 21 309 website: https://smz.ezdrowie.gov.pl Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Drotamax

The medicine should be stored out of sight and reach of children.
Store in a temperature below 30°C.
Do not use this medicine after the expiry date stated on the packaging.
The expiry date refers to the last day of the stated month.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information.

What Drotamax contains

The active substance of the medicine is drotaverine hydrochloride. Each tablet contains 80 mg of drotaverine hydrochloride.
Other ingredients of the medicine are: lactose monohydrate, microcrystalline cellulose, povidone (K-29/32), corn starch, magnesium stearate, talc.

What Drotamax looks like and contents of the pack.

Yellow, round, biconvex tablets with the inscription "80" on one side.
10 or 20 tablets in a transparent PVC/Aluminum blister pack and a cardboard box.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Promedo Pharma Products GmbH;

Anklamer Strasse 28.

10115 Berlin

Germany

Manufacturer
Meditop Pharmaceutical Ltd.
Ady Endre u. 1.
2097 Pilisborosjenő
Hungary

Date of last revision of the leaflet: