Myditin

Patient Information Leaflet

Myditin, 3 mg, tablets
Pridinolum
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet for future reference.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. The medicine may harm others, even if their symptoms are identical.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of Contents

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

1. What Myditin is and what it is used for

Myditin is a medicine that reduces muscle tension. It acts via the central nervous system.
Myditin is used in the treatment of muscle spasticity in adults (muscle spasms of central and peripheral origin):

• low back pain (lumbago),
• neck muscle spasms (torticollis),
• general muscle pain.

2. Important information before taking Myditin

When not to take Myditin

• if the patient is allergic to pridinol or any of the other ingredients of this medicine (listed in section 6);
• if the patient has any of the following conditions:
  • glaucoma,
  • benign prostatic hyperplasia (enlargement of the prostate gland),
  • bladder emptying disorders (urinary retention),
  • mechanical obstruction in the gastrointestinal tract,
  • irregular heartbeat (arrhythmia),
• during the first 3 months of pregnancy.

Warnings and precautions
Before starting treatment with Myditin, discuss this with your doctor or pharmacist.
Exercise particular caution

• If the patient has liver or kidney disease. In these patients, the active substance may be present in the body at higher concentrations and (or) for a longer duration than usual.
• In patients aged 65 years or older.
• If the patient has low blood pressure, as the risk of circulatory disturbances (fainting) may be increased.

Myditin and other medicines
Inform your doctor or pharmacist about all medicines currently taken or recently used, as well as any medicines planned for future use.
Myditin enhances the effects of medicinal products belonging to a group known as anticholinergic drugs.
This applies, for example, to certain medicines used in the treatment of overactive bladder, urinary incontinence, asthma, or Parkinson's disease. See also section 4. "Possible side effects".

Pregnancy, breastfeeding and fertility
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor or pharmacist before using this medicine.
Myditin must not be taken during the first 3 months of pregnancy. During later stages of pregnancy, Myditin may be used only after careful evaluation by a doctor, under medical supervision, and only if absolutely necessary.
Moreover, during the entire breastfeeding period, Myditin should be taken only if prescribed by a doctor.

Driving and operating machinery
A possible side effect of Myditin is temporary visual disturbances. If vision problems occur, patients should not drive, operate machinery, or perform other hazardous activities.

Myditin contains lactose
If the patient has previously been diagnosed with intolerance to certain sugars, he or she should consult a doctor before taking this medicine.

3. How to take Myditin

This medicine should always be taken according to the instructions of the doctor or pharmacist.
If in doubt, consult your doctor or pharmacist.
Recommended dose:
½ to 1 tablet (1.5 – 3 mg of pridinol) three times daily.
Use in children and adolescents
There are no available data regarding the use of Myditin in children and adolescents.
Method of administration
Myditin should be taken orally.
Tablets should be swallowed whole, with an adequate amount of liquid (preferably one glass of
water [200 ml]).
The medicine may be taken independently of meals; however, its effect is faster when taken before
meals.
Patients with low blood pressure should take the tablets after meals to reduce the risk of fainting.
Duration of treatment
Treatment may be long-term. Your doctor will decide for how long you should take Myditin.
If you take more Myditin than you should
If you take more than the recommended dose, contact your doctor. The doctor will decide on the
further course of action. It is possible that the adverse reactions listed in section 4 may be more
severe.
If you forget to take Myditin
Do not take a double dose to make up for the missed dose. Continue taking the medicine as
instructed by your doctor or according to the dosage instructions described in this leaflet.
Stopping Myditin
The original symptoms may recur. In such a case, inform your doctor. If you have any further
doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
When recommended doses are used, adverse reactions occur rarely or not frequently, and usually resolve after dose reduction or discontinuation of the medicine.
The following adverse reactions may occur, especially during concomitant use of certain medicines (anticholinergic drugs):
dry mouth, thirst, transient visual disturbances (pupil dilation, difficulty focusing, light sensitivity, slight increase in intraocular pressure),
redness and dryness of the skin, changes in heart rhythm (slow heartbeat followed by rapid heartbeat),
urinary retention, constipation, and very rarely, vomiting, dizziness, and unsteady gait.

Possible adverse reactions

Not frequently (may affect 1 in 100 patients)

• Rapid heartbeat (tachycardia), circulatory system reactions, low blood pressure,
• Nausea, abdominal pain, dry mouth,
• Fatigue and feeling of weakness (asthenia),
• Dizziness, headache, speech disorders,
• Restlessness.

Rarely (may affect 1 in 1000 patients)

• Impaired ability to focus vision,
• Diarrhea, vomiting,
• Hypersensitivity reactions such as itching, skin redness, swelling or shortness of breath,
• Attention, coordination and taste disturbances,
• Anxiety, depression.

Frequency unknown (frequency cannot be estimated from available data)

• Irregular heartbeat,
• Acute angle-closure glaucoma attack in narrow-angle glaucoma,
• Overheating,
• Muscle weakness,
• Hand tremors, skin discomfort (e.g. tingling, burning, numbness),
• Hallucinations,
• Difficulty urinating

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +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 Myditin

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister. The expiry date refers to the last day of the stated month.
Do not store above 25°C.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Myditin contains
The active substance is pridinol.
One tablet contains 3.02 mg of pridinol (as 4 mg of pridinol mesylate).
The other ingredients are: monohydrate lactose, microcrystalline cellulose, hydrogenated castor oil,
talc, povidone K-30, colloidal anhydrous silica, magnesium stearate.

What Myditin looks like and contents of the pack
Myditin is white, round tablets with a score line on one side. The tablet can be divided into equal doses.
Myditin is available in packs containing 20 tablets.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
SUN-FARM Sp. z o.o.
ul. Dolna 21
05-092 Łomianki

Manufacturer
mibe GmbH Arzneimittel
Münchener Straße 15
06796 Brehna
Germany