PACKAGE LEAFLET: INFORMATION FOR THE USER

TRIHEXYPHENIDYL 2 mg TABLETS

TRIHEXYPHENIDYL 5 mg TABLETS

Read all of this leaflet carefully before you start taking this medicine.

-    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.

Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

-    If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

THIS LEAFLET CONTAINS

1.    What TRIHEXYPHENIDYL is for

2.    Before you take TRIHEXYPHENIDYL

3.    Howto take TRIHEXYPHENIDYL

4.    Possible side effects

5.    Howto store TRIHEXYPHENIDYL

6.    Further information

1. WHAT TRIHEXYPHENIDYL IS FOR

TRIHEXYPHENIDYL belongs to a group of medicines known as the anti-spasmodics. TRIHEXYPHENIDYL works by controlling the symptoms of Parkinson's disease, as well as movement disorders.

This medicine helps control shaking (tremor), muscle rigidity, restlessness, muscle spasm, involuntary movements and increased saliva production.

If you are not sure why you have been prescribed these tablets then please ask your doctor.

2. BEFORE YOU TAKE TRIHEXYPHENIDYL

Do not take TRIHEXYPHENIDYL

•    If you are allergic to TRIHEXYPHENIDYL or any of the other ingredients in the tablets (listed in section 6 of this leaflet)

•    If you are pregnant, planning a pregnancy, or breast-feeding

•    If you have increased eyeball pressure (Glaucoma)

•    If you have a blockage of the urinary tract or gastro-intestinal tract or have an enlarged prostate gland causing difficulty passing urine

•    If you have muscle weakness (Myasthenia gravis).

Take special care with TRIHEXYPHENIDYL

Tell your doctor before you take this medicine if you

•    have high blood pressure or heart problems

•    have problems with your liver, kidneys or stomach

•    are likely to have increased eyeball pressure

•    have mental health problems

•    have a fever.

Taking other medicines

Tell your doctor or pharmacist if you are taking, or have recently taken, any other medicines, even medicines bought without a prescription.

In particular, tell your doctor or pharmacist if you are taking any of the following medicines, as they may affect how TRIHEXYPHENIDYL tablets work:

•    Medicines for depression or anxiety

•    Medicines called phenothiazines for mental health problems

•    Clozapine for schizophrenia

•    Bethanechol, Carbachol or Distigmine for difficulty passing urine

•    Amantadine to treat Parkinson's disease

•    Memantine to treat Alzheimer's disease

•    Antihistamines for allergies

•    Reserpine to treat high blood pressure

•    Disopyramide to treat irregular heartbeat

•    Ketoconazole for fungal infections

•    Nefopam to relieve pain

•    Domperidone or Metoclopramide for nausea and vertigo.

If you go into hospital or have treatment for other conditions, tell the doctor that you are taking TRIHEXYPHENIDYL.

Taking TRIHEXYPHENIDYL with food and drink

If TRIHEXYPHENIDYL tablets make you nauseous, take them after meals. If they give you a dry mouth, take them before meals or try chewing gum, peppermints or drinking water.

Pregnancy and breast-feeding

Do not take TRIHEXYPHENIDYL if you are pregnant, planning a pregnancy or breast-feeding.

Driving and using machines

TRIHEXYPHENIDYL may cause blurred vision or make you less alert. If affected do not drive or operate machinery.

Important information about some of the ingredients of TRIHEXYPHENIDYL

If you have an intolerance to lactose or other sugars contact your doctor before taking TRIHEXPHENIDYL.

3. HOW TO TAKE TRIHEXYPHENIDYL

5. HOW TO STORE TRIHEXYPHENIDYL

Always take TRIHEXPHENIDYL exactly as your doctor has told you.Take this medicine by mouth.

Dosage

Treatment should start at a low dose and be gradually increased until the right dosage has been found.

Adults: Typical doses are 6-10 mg per day for Parkinson's disease and 5-15 mg per day for treating side effects from other drugs. Some patients may need more or less than this.

Elderly: Patients over 60 years of age will be more sensitive and therefore require smaller doses. Follow your doctor's advice.

Children: Not recommended for children.

If you take more TRIHEXYPHENIDYL than you should

Contact your doctor or pharmacist immediately. Show them the package.

If you forget to take TRIHEXYPHENIDYL

Don't worry, just take your next scheduled dose at the correct time. Do not take a double dose to make up for the one you have missed.

Keep out of reach and sight of children.

Do not store above 25°C. Store in the original package.

Do not use these tablets after the expiry date, which is stated on the package. The expiry date refers to the last day of that month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. FURTHER INFORMATION

4. POSSIBLE SIDE EFFECTS

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

Common side effects: dry mouth, blurred vision, dizziness, nausea or nervousness. Most of these side effects are mild and will improve as you continue to take your tablets.

Patients with hardening of the arteries (arterial sclerosis) or with unusual reactions to other drugs may develop mental confusion, hallucinations, forgetfulness, feeling optimistic, anxiety, restlessness, agitation, skin rash, constipation, irregular heartbeat, inability to urinate, sickness or vomiting.

Very rare side effects: Increased eye ball pressure (Glaucoma).

If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

What TRIHEXYPHENIDYL contains

The active ingredient in this medicine is trihexyphenidyl hydrochloride. TRIHEXYPHENIDYL is the new name for Benzhexol. The ingredient itself has not changed.

The other ingredients are lactose monohydrate, maize starch, pregelatinised starch, sodium starch glycollate and magnesium stearate.

What TRIHEXYPHENIDYL looks like and contents of the pack

Trihexyphenidyl 2 mg tablets are round white tablets with the marking MP20 on one side.

Trihexyphenidyl 5 mg tablets are round white tablets with the marking MP21 on one side.

The tablets come in packs containing 28, 30, 50, 56, 60, 84,100, 250, 500 and 1000 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Genethics Europe Limited,

41 -43 Klimentos, Klimentos Tower,

Nicosia 1061, Cyprus

Manufacturer

DDSA Pharmaceuticals Limited,

310 Old Brampton Road,

London SW5 9JQ

For more information about this product, please contact the Marketing Authorisation Holder.

This leaflet was last revised in 04/2016

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