Myditin

Package leaflet: Information for the patient

Myditin 4 mg tablets

Pridinol mesilate
Equivalent medicine
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you personally. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4. Contents of this leaflet:
  1. What Myditin is and what it is used for
  2. What you need to know 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 with a muscle-relaxing effect. This effect occurs through the central nervous system.
Myditin is used in adults to treat muscle tensions resembling cramps (central and peripheral muscle spasms):

• Lower back pain (lumbago)
• Neck spasms (torticollis)
• General muscle pain

2. What you need to know before taking Myditin

Do not take Myditin
if you are allergic to pridinol or to any of the other ingredients of this
medicine (listed in section 6)
if you have any of the following conditions:

• Glaucoma
• Benign enlargement of prostate tissue (urinary retention)
• Gastrointestinal tract obstruction
• Irregular heartbeat (arrhythmia)
• During the first 3 months of pregnancy

Warnings and precautions
Talk to your doctor or pharmacist before taking Myditin.
Exercise particular caution

• If you have liver or kidney problems

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Under these circumstances, the active substance may remain free in your body at
higher concentrations and/or for a longer period than usual.

• If you are aged 65 years or older
• If you suffer from low blood pressure, as the risk of circulatory problems (fainting) may be increased.

Other medicines and Myditin
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Myditin enhances the effect of medicines belonging to the anticholinergic group. This includes, for example, certain medicines used for the treatment of overactive prostate, urinary incontinence, asthma, and Parkinson's disease. See also section 4.
Pregnancy, breastfeeding, and fertility
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding,
ask your doctor or pharmacist for advice before taking this medicine.
During the first trimester of pregnancy, you must not take Myditin. During subsequent months of
pregnancy, Myditin may be taken only after careful medical evaluation, under medical supervision, and only if strictly necessary.
During the entire breastfeeding period, Myditin may be taken only if prescribed by a doctor.
Driving and using machines
A possible side effect of Myditin is temporary vision problems. If you experience vision disturbances, you must not drive vehicles, operate machinery, or perform any other potentially hazardous activities.
Myditin contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, consult him or her before taking this medicine.

3. How to take Myditin

Always take this medicine exactly as instructed by your doctor or
pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is:
Half to one tablet (1.5–3 mg of pridinol) three times a day.
Use in children and adolescents
There are no data available on the use of pridinol in children and adolescents.
Method of administration
Myditin is for oral use.
Take the tablets without chewing and with sufficient liquid (preferably
one glass of water [200 ml]).
The intake is independent of meals. The onset of effect is faster when the
medicine is taken before meals.
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However, if you suffer from low blood pressure, take the tablet after a meal to reduce the risk
of fainting.
Duration of treatment
Treatment may be required for a prolonged period. Your doctor will decide for how long
you should take Myditin.
If you take more Myditin than you should
Inform your doctor. The doctor may determine the necessary measures. The adverse effects
listed in section 4 may occur more severely.
If you forget to take Myditin
Do not take a double dose to make up for the forgotten tablet. Continue taking the medicine as prescribed by your doctor or as described in the dosage instructions.
If you stop taking Myditin
The original symptoms may recur. Inform your doctor also in this case. If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
At the recommended doses, side effects range from rare to common and usually disappear
after a dose reduction or after stopping treatment.
The following side effects may occur, especially during concomitant use of certain medicines (anticholinergic medicines):
Dry mouth, thirst, temporary vision problems (dilated pupils, blurred vision, light sensitivity, slight increase in eye pressure),
skin redness and dryness, changes in heart rhythm (slowed heartbeat followed by rapid heartbeat),
difficulty urinating (urinary disturbances), constipation, and very rarely, vomiting, dizziness, and unsteady gait.

Possible side effects

Uncommon (may affect up to 1 in 100 people)

• Fast heartbeat (tachycardia), circulatory reactions, low blood pressure
• Nausea, abdominal pain, dry mouth
• Tiredness and feeling of weakness (asthenia)
• Dizziness, headache, altered speech
• Restlessness

Rare (may affect up to 1 in 1,000 people)

• Blurred vision (impaired ability to focus)
• Diarrhoea, vomiting
• Hypersensitivity reactions such as itching, skin redness, swelling, or difficulty breathing
• Impaired attention, coordination, and taste
• Anxiety, depression

Not known (frequency cannot be estimated from the available data)
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• Irregular heartbeat
• Acute glaucoma attack in closed-angle glaucoma
• Heat retention
• Muscle weakness
• Hand tremor, skin problems (such as thinning, sunburn, numbness)
• Hallucinations
• Urinary problems

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse.
You can also report side effects directly via the national reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Myditin

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister pack after Exp. The expiry date refers to the last day of that month.
Do not store above 25°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents 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 components are: monohydrate lactose, microcrystalline cellulose, hydrogenated castor oil, talc, povidone K30, colloidal silicon dioxide, magnesium stearate.

Description of the appearance of Myditin and contents of the pack
The tablets are white, round and have a score line on one side. The tablet
can be divided into two equal doses.
Pack sizes of 20, 50 and 100 tablets.
Hospital packs of 200 (10x20), 500 (10x50) and 1000 (10x100) tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
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mibe pharma Italia S.r.l.
Via Leonardo da Vinci 20/B
39100 Bolzano
Manufacturers responsible for batch release
Biokirch GmbH Pharmaproduktion und Aerzteservice
Bei den Kämpen 11
21220 Seevetal
Germany
mibe GmbH Arzneimittel
Münchener Strasse 15
06796 Brehna
Germany
This medicinal product is authorised in the European Economic Area countries with
the following names:
Germany: Pridinol Strathmann 3mg Tabletten
Austria: Myopridin 3 mg Tabletten
Italy: Myditin 4 mg tablets
Poland: Myditin
Spain: Myditin 3 mg Comprimidos EFG
United Kingdom: Myopridin 3 mg Tablets
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