PILOCARPINE HYDROCHLORIDE 5 MG FILM-COATED TABLETS - patient leaflet, side effects, dosage

12. what you need to know before you take pilocarpine hydrochloride tablets

;3. How to take Pilocarpine Hydrochloride Tablets

14. Possible side effects

|5. How to store Pilocarpine Hydrochloride Tablets

16. contents of the pack and other information

1. what pilocarpine hydrochloride is and what it is used for

jThe name of this medicine is Pilocarpine Hydrochloride Tablets. The active ingredient is pilocarpine Ihydrochloride, which belongs to a group of medicines called parasympathomimetic agents or [cholinergic agents.

[Pilocarpine Hydrochloride stimulates certain nerves and glands in your body. After you take Pilocarpine ; Hydrochloride, your body will produce more saliva, tears, sweat, gastric juices and mucus.

pilocarpine Hydrochloride is used;

• > If you have been given radiotherapy for cancer of the head or neck, and your mouth feels very dry

• ■ If you have been diagnosed with a condition called Sjogren’s syndrome, and your mouth and/or your;

eyes are dry

[|f you have any questions about how Pilocarpine Hydrochloride works or why this medicine has been prescribed for you, ask your doctor.

2. what you need to know before you take pilocarpine hydrochloride tablets

Do not take Pilocarpine Hydrochloride Tablets if:

• ■ You are allergic to pilocarpine hydrochloride or to any of the other ingredients of this medicine (listed in section 6).

• ■ You have uncontrolled asthma.

• > You have uncontrolled heart or kidney disease.

• ■ You have a chronic disease which can worsen because of treatment with a medicinal product that acts like Pilocarpine Hydrochloride. Talk to your doctor if you are not sure.

• ■ You have any disorder in which you are to avoid constriction of the pupil of the eye (e.g., an acute inflammation of the iris of the eye).

Ilf you suffer from any of the above, speak to your doctor or pharmacist before taking Pilocarpine

;Hyd rochloride Tablets.

Warnings and Precautions

[Tell your doctor before you take Pilocarpine Hydrochloride if you have any:

• > Lung problems (e.g. asthma, chronic bronchitis and/or chronic obstructive pulmonary disease)

• ■ Serious heart problems (e.g. heart failure, irregular pulse)

• > Gallbladder or bile duct problems (e.g. gallstones)

• ■ Stomach or intestinal problems (e.g. ulcers)

[■ Cognitive problems (e.g. difficulties in learning, memory, perception, and problem solving) or mental problems

• > Kidney problems (e.g. renal insufficiency or kidney stones)

; Eve problems (e.g. narrow-anale glaucoma)

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[Excessive sweating

[If you sweat excessively during Pilocarpine Hydrochloride treatment, drink more liquids. If you cannot Id ri nk enough liquids, contact your doctor as you may suffer from dehydration and organ damage if [this continues.

[Children and adolescents

[This medicine should not be given to children or adolescents younger than 18 years of age.

Other medicines and Pilocarpine Hydrochloride Tablets

[Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, [including medicines obtained without a prescription. Taking some medicines together can be harmful.

lit is especially important to tell your doctor if you are taking any medicines to treat:

• ■ Beta blockers (medicines used to treat high blood pressure, heart problems or eye problems)

I* Medicines for diarrhoea (e.g. atropine)

• ■ Medicines for asthma (e.g. ipratropium inhaler)

[■ Medicines that activate so-called parasympathetic nervous system (e.g. some medicines for glaucoma, nervous system or mental diseases, Alzheimer's di­sease, or medicines used to speed up gastric or intestinal passage)

• ■ Medicines that are broken down by the liver enzyme called CYP2A6, e.g., blood pressure lowering medicine irbesartan or medicines to prevent blood clotting (warfarin, dicoumarol)

Ilf you are unsure of the types of medicines you are taking, ask your doctor or pharmacist.

[Pregnancy, breast-feeding and fertility

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

[Pregnancy

[Do not use Pilocarpine Hydrochloride during pregnancy unless your doctor recommended it. If you

[are a woman of childbearing potential, you should use an effective contraception to prevent pregnancy [while taking this medicine. Ask your doctor for advice.

[Breast-feeding

[It is not known whether pilocarpine passes into human milk. Your doctor will tell you whether you [should stop treatment with Pilocarpine Hydrochloride or breast-feeding.

[Fertility

This medicine may impair fertility in men and women. If you are planning to father a child, ask your [doctor for advice before taking this medicine.

[Driving and using machines

[This medicine may cause dizziness or affect your vision, in particular, you may have problems seeing

[well at night. If this happens to you, do not drive or use any tools or machines.

3. how to take pilocarpine hydrochloride tablets

[Always take this medicine exactly as your doctor or pharmacist has told you. You should check with [them if you are not sure.

The recommended dose is:

[For patients who have been treated with radiotherapy for head and neck cancer:

!■ The recommended dose for adults is one 5 mg tablet three times a day.

• ■ Make sure you take your last tablet of the day with your evening meal.

IFor patients who have been diagnosed with Sjogren’s syn­drome:

• ■ The recommended dose for adults is one 5 mg tablet four times a day.

I* Make sure that you take your last tablet of the day just before you go to bed.

[Depending on how you respond to treatment, your doctor may suggest a higher or lower dose. The dose

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mm )■ If you have cirrhosis (liver disorder), your doctor will start your treatment at a lower daily dose. ^Depending on how you respond to treatment, your doctor may gradually increase your dose up to the

recommended daily dose.

Method of administration:

r Pilocarpine Hydrochloride should only be taken by mouth.

; Take Pilocarpine Hydrochloride tablets with a glass of water during, or directly after, meals.

r Try to take your tablets at intervals spread out evenly over the day, e.g. take your first tablet in the morning, one in the afternoon and one in the evening.

Duration of treatment:

your doctor will tell you exactly how long you will need to take the tablets. If no improvement is noted after 2–3 months your doctor may decide to discontinue therapy.

if you take more Pilocarpine Hydrochloride Tablets than you should:

Ilf you accidentally take too many tablets, or someone else takes any of your medicine, you should tell ■your doctor at once or contact the nearest accident and emergency department. Show any left-over imedicines or the empty packet to the doctor.

lOverdose symptoms may include stomach cramps, diarrhoea, nausea and vomiting, unwanted passage ■of stool and urine, sweating, salivation, increased secretion from the bronchi, shrinking of eye pupil, Slow heartbeat, low blood pressure, muscle spasms or twitching, and general weakness.

If you forget to take Pilocarpine Hydrochloride Tablets: bo not take a double dose to make up for a forgotten tablet.

If you stop taking Pilocarpine Hydrochloride Tablets:

;Do not stop taking your medicine unless your doctor tells you to.

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

4. possible side effects

Like all medicines, Pilocarpine Hydrochloride Tablets can cause side effects, although not everybody gets them.

Very common (may affect more than 1 in 10 people):

• ■ flu-like symptoms

? sweating

• ■ headache

? the need to pass urine more frequently

Common (may affect more than 1 in 100 but less than 1 in 10 people):

!■ weakness

• * chills

!■ runny nose

7 allergic reactions including rash and itching

!■ dizziness (more likely in patients older than 65 years)

• * diarrhoea; constipation

!■ indigestion; abdominal pain; nausea; vomiting

!■ watering of the mouth

!■ flushing; rise in blood pressure

• * palpitations (feeling your heart beating faster, harder or skipping a beat)

5. how to store pilocarpine hydrochloride tablets

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

IDo not use Pilocarpine Hydrochloride Tablets after the expiry date on the carton and blister as ;[EXP XX/YYYY], The expiry date refers to the last day of that month.

;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 Pilocarpine Hydrochloride Tablets contain:

Each tablet contains 5 mg of pilocarpine hydrochloride as the active ingredient.

The tablets also contain microcrystalline cellulose, pregelatinised starch, stearic acid and colloidal [anhydrous silica. The coating is composed of opadry white 0Y-7300 (containing hypromellose, titanium dioxide [E171] and macrogol 400).

|What Pilocarpine Hydrochloride Tablets look like and contents of the pack:

The tablets are white to off white circular, biconvex film coated tablets with embossing “P 5”.

■Pilocarpine Hydrochloride Tablets are available in boxes of 14,21,28 or 84 tablets. Not all pack sizes imay be marketed.

Marketing Authorisation Holder

ISomex Pharma, illford, Essex, IG3 8BS. UK.

Manufacturer

Somex Pharma, illford, Essex, IG3 8RA. UK.

This leaflet was last revised in 10/2021

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297 mm