Drotamax

Drotamax, 80 mg, tablets
Drotaverini hydrochloridum
Please read the leaflet carefully before using the medicine, as it contains important information for the patient.
This medicine should always be used exactly as described in the patient leaflet or as advised by the physician or pharmacist.

• Keep this leaflet, so that you can read it again if necessary.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after 7 days, or if your condition worsens, consult your doctor.

Leaflet Contents

1. What Drotamax is and what it is used for
2. Important information before taking Drotamax
3. How to take Drotamax
4. Possible side effects
5. How to store Drotamax
6. 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:

• Spasms of smooth muscles associated with biliary tract diseases: gallstones, cholelithiasis of bile ducts, cholecystitis, pericholecystitis, cholangitis, inflammation of the Vater's papilla;
• Spasms of smooth muscles associated with urological disorders: nephrolithiasis, ureteric stones, pyelitis, cystitis, and painful urinary urgency.

Drotamax may also be used as supportive treatment in:

• Gastrointestinal tract spasms: gastric and duodenal ulcer disease, gastritis, gastric spasms, intestinal inflammations, irritable bowel syndrome with spasmodic constipation or intestinal flatulence;
• Gynecological conditions: dysmenorrhea (painful menstruation).

If there is no improvement or if symptoms worsen, medical advice should be sought.

2. Important information before using DROTAMAX

When not to take DROTAMAX:

• if the patient is allergic to the active substance (drotaverine) or to any of the other ingredients of this medicine (listed in section 6);
• if the patient has severe liver, kidney or heart failure;
• if the patient is under 12 years of age.

Warnings and precautions
Caution should be exercised when using drotaverine in patients with hypotension.
DROTAMAX and other medicines
You should tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Concomitant use of drotaverine with levodopa (a medicine used in Parkinson's disease) reduces the effect of levodopa, which may lead to increased skeletal muscle rigidity and tremor.
Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
Pregnancy
Drotaverine crosses the placenta.
This medicine should not be used during labour.
Breastfeeding
Use of this medicine is not recommended during breastfeeding due to lack of adequate data from clinical studies.
Driving and using machines
DROTAMAX, when taken at usual doses, generally does not affect the ability to drive or operate machinery. However, if dizziness occurs after taking this medicine, potentially hazardous activities such as driving or operating machinery should be avoided.
DROTAMAX contains lactose.
If the patient has previously been diagnosed with an intolerance to certain sugars, the patient should consult their doctor before taking this medicine.

3. How to use DROTAMAX

This medicine should always be taken exactly as described in the patient information leaflet or as directed by a physician or pharmacist. If in doubt, consult a physician or pharmacist.

Adults:

• 1 tablet 2 or 3 times daily

Use in children and adolescents
Clinical studies on the use of drotaverine in children have not been conducted. If use of the medicine is necessary, children above 12 years of age should take 1 tablet 1 or 2 times daily. The maximum daily dose for children is 160 mg, i.e. 2 tablets.

Without consulting a physician, the medicine may be used for a maximum of 7 days.

Taking more DROTAMAX than recommended
If a patient exceeds the recommended dose by one tablet, this usually does not cause any adverse effects.
In case of overdose, medical advice should be sought immediately.

Missed dose of DROTAMAX
Do not take a double dose to make up for a missed dose.

If you have any further questions about the use of this medicine, consult your physician or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.

Rare (occurring in 1 to 10 out of 10,000 patients):
Headache, dizziness, nausea, palpitations, insomnia, constipation, hypotension, and allergic reactions (swelling, urticaria, rash, itching).

Reporting of adverse reactions
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions 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

Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store DROTAMAX

Keep the medicine out of the sight and reach of children.
Store 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 must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What DROTAMAX contains
The active substance is drotaverine hydrochloride. Each tablet contains 80 mg of drotaverine hydrochloride.
Other components 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 engraved mark "80" on one side.
Available in packs containing 10 or 20 tablets in transparent PVC/Aluminium blisters, packed in a cardboard box.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Promedo Pharma Products GmbH
Anklamer Strasse 28
10115 Berlin
Germany

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