Document: leaflet MAH GENERIC_PL 30684-0125 change

• leaflet MAH GENERIC_PL 20117-0094
• leaflet MAH GENERIC_PL 30684-0125
• leaflet MAH GENERIC_PL 44710-0017

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Glycopyrronium Bromide 1 mg tablets Glycopyrronium Bromide 2 mg tablets

Glycopyrronium Bromide (or Glycopyrrolate)

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

-    Please 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.

-    The full names of these medicines are Glycopyrronium Bromide 1mg tablets and Glycopyrronium Bromide 2mg tablets but within the leaflet it will be referred to as Glycopyrronium Bromide tablets.

In this leaflet:

1.    What Glycopyrronium Bromide tablets are and what they are used for.

2.    What you need to know before you take Glycopyrronium Bromide tablets.

3.    How to take Glycopyrronium Bromide tablets.

4.    Possible side effects.

5.    How to store Glycopyrronium Bromide tablets.

6.    Contents of the pack and other information

1.    WHAT GLYCOPYRRONIUM BROMIDE TABLETS ARE AND WHAT THEY ARE USED FOR

The name of your medicine is Glycopyrronium Bromide tablets. Glycopyrronium Bromide tablets contain a medicine called Glycopyrronium Bromide or Glycopyrrolate. This medicine belongs to a group of medicines called anticholinergics. Glycopyrronium bromide is an antimuscaranic agent.

Glycopyrronium bromide works by inhibiting the action of acetylcholine on peripheral acetylcholine (muscarinic) receptors on smooth muscle, cardiac muscle, the sinoatrial and atrioventricular nodes, exocrine glands, and to a lesser degree, autonomic ganglia. In this manner, it diminishes the volume and free acidity of gastric secretions and controls excessive pharyngeal, tracheal, and bronchial secretions.

Glycopyrronium Bromide tablets are indicated for use in adults as add-on therapy in the treatment of peptic ulcer.

2.    BEFORE YOU TAKE GLYCOPYRRONIUM BROMIDE TABLETS Do not take Glycopyrronium Bromide tablets if:

-    you are allergic to Glycopyrronium bromide, any other anticholinergic or any other of the other ingredients of this medicine (listed in section 6). Signs of an allergic reaction include a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue,

-    you are intolerant to or cannot digest some sugars (as the tablet contains lactose),

-    you have glaucoma (an eye problem),

-    you have difficulty or pain passing water (urine) such as men with prostate problems,

-    you have an obstruction in your gut (gastrointestinal tract), or it is inflamed or does not function normally. These may show themselves as abdominal pain, bloating, reflux or fever,

-    you have a bowel condition call “ileus” (in the small intestine),

-    you have heart problems following severe bleeding,

-    you have inflammation of the bowel (small or large intestine),

-    you have megacolon (a very large enlarged bowel),

-    you have something called “myasthenia gravis” (a very rare muscle weakness problem),

-    You are pregnant, likely to get pregnant, or are breast-feeding.

Talk to your doctor or pharmacist before taking Glycopyrronium Bromide tablets if:

-    you have a problem with your thyroid gland such as an overactive thyroid gland,

-    you have autonomic neuropathy (a disease of the nervous system affecting the bladder muscles, the heart, the digestive tract and the genital organs),

-    you have liver or kidney problems,

-    you have hiatus hernia (a condition in which a portion of the stomach protrudes upward into the chest, through an opening in the diaphragm).

Taking other medicines

Please tell your doctor or pharmacist if you are taking, or have recently taken or might take any other medicines, including any medicines obtained without a prescription. This is because Glycopyrronium Bromide tablets can affect the way some other medicines work.

In particular, tell your doctor if you are taking any of the following medicines. This is because it can increase the chances of you getting side effects, when taken with Glycopyrronium Bromide tablets:

-    medicines for depression called “tricyclic antidepressants” such as doxepin,

-    medicines for severe mental illness called 'antipsychotics' such as haloperidol or phenothiazine,

-    potassium chloride tablets used to prevent or treat low amounts of potassium in the blood,

-    digoxin (used to treat heart problems),

-    amantadine (used to treat Parkinson's disease).,

-    atenolol (used to treat hypertension),

-    metformin (used to treat diabetes),

-    levodopa (used to treat Parkinson's disease),

-    codeine or Methadone (used to treat pain),

-    reserpine (used to treat high blood pressure and mental disorders),

-    medicines for depression (isocarboxazid, linezolid, methylene blue, moclobemide, phenelzine, procarbazine, rasagiline, selegiline, tranylcypromine).

If your doctor has prescribed a medical test, tell your doctor that you are taking Glycopyrronium Bromide tablets, as this may interfere with some test results.

Pregnancy, breast-feeding and fertility

Do not take this medicine if you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby.

Driving and using machines

You may get side effects after taking this medicine, including blurred vision and feeling dizzy. Some of these side effects can affect you being able to concentrate and your reaction speed. If this happens, do not drive or carry out any work that requires a high level of attention.

3. HOW TO TAKE GLYCOPYRRONIUM BROMIDE TABLETS

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

Taking this medicine

-    Take this medicine by mouth.

-    Swallow the tablets whole with a drink of water.

-    The tablets may be taken just before or with meals or food.

How much to take

-    Your doctor will decide on how many Glycopyrronium Bromide tablets you should take.

-    The dose will depend on your condition and its severity.

-    The length of your treatment will depend on how serious your condition is.

-    If you feel the effect of your medicine is too weak or strong, do not change the dose yourself, but ask your doctor.

Use in adults

One tablet of Glycopyrronium Bromide 1mg tablet, three times daily (in the morning, early afternoon and at bedtime).

One tablet of Glycopyrronium Bromide 2mg tablet, three times daily (in the morning, early afternoon and at bedtime).

Continue to take this medicine until the course is completed or until your doctor tells you to stop. Do not stop taking your medicine, even if you feel better. If you stop the treatment too early your problem could come back.

Adults and the elderly with kidney problems

Your doctor may need to give you a lower dose.

Children and adolescents

This medicine must not be given to children below 12 years of age.

If you take more Glycopyrronium Bromide Tablets than you should

If you accidentally take more tablets than you should, or if a child has taken some of the medicine by mistake, tell a doctor or get other medical advice straight away. Take the medicine pack with you. This is so the doctor knows what you have taken. The following effects may happen: difficulty in breathing, fever, pain, jerky movements, tiredness, muscle pain and weakness, unusual excitement, nervousness, restlessness or irritability, unusual fast heartbeat, unusual warmth, dryness and flushing of skin.

If you forget to take Glycopyrronium Bromide tablets

If you forget to take a dose, take it as soon as you remember unless it is » nearly time for your next dose.    jq

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Paper Size : 297mm (H) x 210mm (L) Font: Arial (8 Point)

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If you stop taking Glycopyrronium Bromide tablets

Do not stop taking Glycopyrronium Bromide tablets just because you feel better. It is important that you complete the course of tablets that your doctor has prescribed for you.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4.    POSSIBLE SIDE EFFECTS

Like all medicines, Glycopyrronium Bromide tablets can cause side effects, although not everybody gets them.

Stop taking Glycopyrronium Bromide tablets and see a doctor or go to a hospital straight away if you notice the following side effects:

-    difficulty breathing,

-    fainting,

-    swelling of the face, lips or throat,

-    skin rashes,

-    severe skin reactions including large fluid-filled blisters, sores and ulcers,

-    ulcers in the mouth and throat,

-    fever and heat stroke due to decreased sweating,

-    diarrhoea which may be a symptom of incomplete intestinal obstruction,

-    confusion, dizziness, feeling faint or lightheadedness.

Tell your doctor if any of the following side effects get serious or last longer than a few days:

Very Common

-    Nasal congestion, vomiting, diarrhea, dry mouth, dry nose, flushing, pain. Common

-    Infections of respiratory tract, urinary tract and skin, gastroenteritis, ear infections, oral herpes, hypokalemia (low concentration levels of potassium in blood), hypematraemia (high concentration levels of sodium in blood), dehydration, drowsiness, restlessness, agitation, insomnia, somnolence, headache, convulsions, disturbances in attention, increased heart rate, cough, nausea, abdominal pain or diarrhoea, constipation, chapped lips, dysuria, urinary retention or decreased urine output, pain, falls, loss of taste, blurred vision, abdominal distention, rash, urticaria, dry skin, decreased sweating.

Uncommon

-    Metabolic acidosis, flatulence, abnormal behaviour, irritability.

Rare

-    Impotence, aggression, confusion, nervousness, mood alterations, pupil dilatation, cycloplegia (paralysis of the ciliary muscle of the eye), increased ocular tension, dizziness, pallor, feeling faint, lightheadedness, suppression of lactation, weakness, skin rash or hives.

Very rare

-    Palpitations.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the UK: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

5.    HOW TO STORE GLYCOPYRRONIUM BROMIDE TABLETS

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

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

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

HDPE bottle : Do not use after five weeks of first opening.

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.

If your tablets become discoloured or show any other signs of deterioration, consult your pharmacist who will tell you what to do.

6.    CONTENTS OF THE PACK AND OTHER INFORMATION What Glycopyrronium Bromide tablets contain

The active ingredient is Glycopyrronium bromide (or Glycopyrrolate).

Each Glycopyrronium Bromide 1 mg tablet contains 1 mg of Glycopyrronium bromide.

Each Glycopyrronium Bromide 2mg tablet contains 2mg of Glycopyrronium bromide.

The other ingredients are:

lactose monohydrate, anhydrous calcium hydrogen phosphate, magnesium stearate, povidone K-30, sodium starch glycollate.

Paper Size : 297mm (H) x 210mm (L) Font: Arial (8 Point)