What is a Patient Information Leaflet and why is it useful?

The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.

Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.

The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL 49452/0010.


Myopridin

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Myopridin 3 mg tablets

Pridinol

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

  • Keep this leaflet. You may need to read it again.
  • If you have any further questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
  • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1. What Myopridin is and what it is used for
2. What you need to know before you take Myopridin
3. How to take Myopridin
4. Possible side effects
5. How to store Myopridin
5. Contents of the pack and other information

1. WHAT MYOPRIDIN IS AND WHAT IT IS USED FOR

Myopridin is a medicine that relaxes the muscles. This effect occurs via the central nervous system.

Myopridin is used in adults for the treatment of cramp-like muscle tension (central and peripheral muscle spasms):

  • Low back pain (lumbago)
  • Neck spasm (torticollis)
  • General muscle pain

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE MYOPRIDIN

Do not take Myopridin

  • if you are allergic to pridinol or any of the other ingredients of this medicine (listed in section 6).
  • if you have any of the following diseases:
    • Glaucoma
    • Benign enlargement of the prostate tissue (prostate hypertrophy)
    • Problems emptying the bladder (urinary retention)
    • Blockage of the gastrointestinal trac
    • Irregular heartbeat (arrhythmia)
  • in the first 3 months of pregnancy

Warnings and precautions

Talk to your doctor or pharmacist before taking Myopridin.

Take special care

  • if you have liver or kidney problems In these circumstances, the active substance may be available in your body at a higher concentration and/or for a longer period than usual.
  • if you are 65 years and older
  • if you suffer from low blood pressure, as the risk of circulatory problems (fainting) may be increased.

Other medicines and Myopridin

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Myopridin increases the effect of medicines from the anticholinergic group. Members includes, e.g., certain medicines that are used for overactive bladder, urinary incontinence, asthma treatment and in Parkinson disease. See also section 4.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

In the first 3 months of pregnancy you must not take Myopridin. During the following months of pregnancy you may take Myopridin only after careful consideration by your doctor, under medical supervision and only if absolutely necessary.

Also, during the whole breast-feeding period, you may only take Myopridin if your doctor prescribes it.

Driving and using machines

Temporary vision disorders may be a possible side effect of Myopridin. If you develop vision disorders, you must not drive any vehicles, operate machinery or perform any other dangerous activities.

Myopridin contains Lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. HOW TO TAKE MYOPRIDIN

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

The recommended dose is:

½ to 1 tablet (1.5 - 3 mg pridinol) 3 times daily

Use in children and adolescents

No data are available on the use of Myopridin in children and adolescents.

Method of administration

Myopridin is for oral use.

Take the tablets without chewing them and with sufficient fluid (preferably 1 glass of water [200 ml]).

Administration is independent of meals, with the onset of the effect being faster when the medicine is taken before meals.

However, if you suffer from low blood pressure, take the tablets after meals to reduce the risk of fainting.

Duration of treatment

Treatment may take place over prolonged period. Your doctor will decide for how long you should take Myopridin.

If you take more Myopridin 3 mg than you should, please notify a doctor. The doctor can decide what measures are required. Possibly the side effects listed in section 4 may occur more severely.

If you forget to take Myopridin, do not take a double dose to make up for a forgotten tablet. Continue taking it as prescribed by your doctor or as described in these dosing instructions.

If you stop taking Myopridin, your original symptoms may recur. Notify your doctor in this case as well. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

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

At the stated doses, side effects are rare to uncommon, and generally disappear after a dose reduction or after discontinuation the medicine.

The following side effects may occur, particularly during simultaneous use of certain medicines (anticholinergic medicines):

Dry mouth, thirst, temporary visual disorders (dilated pupils, problems focusing, sensitivity to light, slight rise in eye pressure), redness and dryness of the skin, changes in heart rhythm (slow heartbeat followed by racing heartbeat), disorders of urination (micturition disorders), constipation and, very rarely, vomiting, dizziness and unsteady gait.

Possible side effects

Uncommon (may affect up to 1 in 100 people)

  • Racing heart (tachycardia), circulatory reactions, low blood pressure
  • Nausea, abdominal pain, dry mouth
  • Fatigue and a feeling of weakness (asthenia)
  • Dizziness, headache, impaired speech
  • Restlessness

Rare (may affect up to 1 in 1000 people)

  • Impaired ability to focus, impaired vision
  • Diarrhoea, vomiting
  • Hypersensitivity reactions such as itching, redness of the skin, swelling or shortness of breath
  • Impaired attention, coordination, taste
  • Anxiety, depression

Not known (frequency cannot be estimated from the available data)

  • Irregular heartbeat
  • Glaucoma crisis in narrow-angle glaucoma
  • Heat accumulation
  • Muscle weakness
  • Tremor of the hand, skin discomfort (such as tingling, burning, numbness)
  • Hallucinations
  • Problems with urination

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

5. HOW TO STORE MYOPRIDIN

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and blister. The expiry date refers to the last day of that month.

Do not store above 25 °C.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Myopridin contains

The active substance is Pridinol.

1 tablet contains 3.02 mg pridinol as 4 mg pridinol mesilate.

The other ingredients are: lactose monohydrate, microcrystalline cellulose, hydrogenated castor oil, talc, povidone K30, colloidal silicon dioxide, magnesium stearate

What Myopridin looks like and contents of the pack

The tablets are white, round and have a score line on one side. The tablet can be divided into equal doses.

There are packs with 20, 50 and 100 tablets.

Hospital packs with 200 (10 x 20), 500 (10 x 50) and 1000 (10 x 100) tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

mibe pharma UK Ltd
4 Coleman Street
6th Floor
London
EC2R 5AR
United Kingdom

Manufacturer

mibe GmbH Arzneimittel
Münchener Straße 15
06796 Brehna
Germany

This medicinal product is authorised in the Member States of the EEA under the following names:

Germany: Pridinol Strathmann 3 mg Tabletten

Italy: Myditin 4 mg Compresse

Poland: Myditin

Spain: Myditin 3 mg Comprimidos EFG

Austria: Myopridin 3 mg Tabletten

United Kingdom: Myopridin 3 mg Tablets

This leaflet was last revised in August 2020.