Miditin

Leaflet attached to the packaging: patient information

Myditin, 3 mg, tablets

Pridinolum

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

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed to a specific person. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Myditin and what is it used for
• 2. Important information before taking Myditin
• 3. How to take Myditin
• 4. Possible side effects
• 5. How to store Myditin
• 6. Package contents and other information

1. What is Myditin and what is it used for

Myditin is a muscle relaxant. It works by acting on the central nervous system.
Myditin is used to treat muscle spasms in adults (muscle spasms of central and peripheral origin):

• lower back pain (lumbago),
• neck muscle spasm (torticollis),
• general muscle pain.

2. Important information before taking Myditin

When not to take Myditin

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

Warnings and precautions

Before starting to take Myditin, the patient should discuss it with their doctor or pharmacist.

Special caution is required

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

Myditin and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking, have recently taken, or plan to take.
Myditin enhances the effect of medicinal products from the group called anticholinergic medicines.
This includes, for example, some medicines used to treat 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 or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
In the first 3 months of pregnancy, Myditin should not be taken. In subsequent months of pregnancy, Myditin can only be used after careful evaluation by the doctor, under the doctor's supervision, and only if absolutely necessary.
Additionally, during the entire breastfeeding period, Myditin can only be taken if prescribed by a doctor.

Driving and using machines

A possible side effect of Myditin may be temporary vision disturbances. In case of vision problems, the patient should not drive, operate machines, or perform other hazardous activities.

Myditin contains lactose

If the patient has been diagnosed with intolerance to some sugars, they should contact their doctor before taking the medicine.

3. How to take Myditin

This medicine should always be taken exactly as prescribed by the doctor or pharmacist. In case of doubts, the patient should consult their doctor or pharmacist.
Recommended dose:
½ to 1 tablet (1.5 – 3 mg prydinol) 3 times a day.

Use in children and adolescents

There are no available data on the use of Myditin in children and adolescents.

Method of administration

Myditin should be taken orally.
The tablets should be taken without chewing, with a sufficient amount of liquid (preferably 1 glass of water [200 ml]).
The medicine should be taken regardless of meals; however, the effect is faster when taken before a meal.
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. The doctor will decide how long the patient should take Myditin.

Taking a higher dose of Myditin than recommended

In case of taking a higher dose than recommended, the patient should consult their doctor. The doctor will decide on further action. Possible side effects listed in section 4 may be more severe.

Missing a dose of Myditin

The patient should not take a double dose to make up for a missed dose. They should continue taking the medicine as prescribed by the doctor or according to the dosage description in this leaflet.

Stopping Myditin treatment

There may be a recurrence of the original symptoms. In such a case, the patient should inform their doctor. If they have any further doubts about the use of this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Myditin can cause side effects, although not everybody gets them.
When using the recommended doses, side effects are rare or not very common and usually disappear after reducing the dose or stopping the medicine.
The following side effects may occur, especially when taking certain medicines (anticholinergic medicines) at the same time:
dry mouth, thirst, transient vision disturbances (pupil dilation, concentration disorders, sensitivity to light, slight increase in intraocular pressure),
redness and dryness of the skin, changes in heart rhythm (slow heartbeat, followed by rapid heartbeat), urinary disorders, constipation, and very rarely, vomiting, dizziness, and unsteady gait.

Possible side effects

Uncommon (may affect up to 1 in 100 people)

• rapid heartbeat (tachycardia), cardiovascular reactions, low blood pressure,
• nausea, abdominal pain, dry mouth,
• fatigue and weakness (asthenia)
• dizziness, headache, speech disorders,
• anxiety.

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

• disturbed accommodation,
• diarrhea, vomiting,
• hypersensitivity reactions, such as itching, skin redness, swelling, or shortness of breath,
• attention, coordination, taste disorders,
• anxiety, depression.

Frequency not known (frequency cannot be estimated from the available data)

• irregular heartbeat,
• angle-closure glaucoma in patients with narrow angles,
• hyperthermia,
• muscle weakness,
• tremors, skin disorders (e.g., tingling, burning, numbness),
• hallucinations,
• urinary retention

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should inform their 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
Phone: +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, more information can be gathered on the safety of the medicine.

5. How to store Myditin

The medicine should be stored 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 month.
Do not store above 25°C.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer use. This will help protect the environment.

6. Package contents and other information

What Myditin contains

The active substance is prydinol.
One tablet contains 3.02 mg of prydinol (as 4 mg prydinol mesylate).
The other ingredients are: lactose monohydrate, 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 a white, round tablet with a dividing line on one side. The tablet can be divided into equal doses.
Myditin is available in packs containing 20 tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder

SUN-FARM Sp. z o.o.
ul. Dolna 21
05-092 Łomianki

Manufacturer

mibe GmbH Arzneimittel
Münchener Straße 15
06796 Brehna
Germany
Date of last revision of the leaflet:08.2020