5 mg film-coated tablets
Pilocarpine hydrochloride
What the Sale is and what it is used for
The active substance in Salagen is pilocarpine hydrochloride. Pilocarpine hydrochloride belongs to a group of medicines called parasympathomimetics or cholinergic substances.
Salvage works by stimulating certain nerves and glands in the body. While taking Salagen, your body will produce more saliva, tears, sweat, gastric juice, and mucus.
The salage is used:
- if you have received radiation therapy for cancer of the head or neck and you suffer a lot from dry mouth.
- if you have been diagnosed with Sjögren’s syndrome and suffer from dry mouth and/or dry and/or itchy eyes.
Pilocarpine hydrochloride contained in Salagen may also be approved for the treatment of other diseases not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
If you have any questions about how Salagen works and why this medicine has been prescribed for you, talk to your doctor.
What you need to know before taking Salagen
Do not use Salagen:
- if you are allergic to pilocarpine hydrochloride or any of the other ingredients of this medicine (listed in section 6).
- if you have untreated asthma
- if you have any heart or kidney disease that is not under control.
- if you suffer from a chronic illness that can be aggravated by treatment with drugs that work in the same way as Salagen. Talk to your doctor if you are unsure.
- if you have a disease where you should avoid contraction of the pupil of the eye (eg an acute inflammation of the iris of the eye
If any of the above apply to you, contact your doctor before using Salagen.
Warnings and cautions
Talk to your doctor or pharmacist before using Salgen.
Tell your doctor before taking Salagen if you have problems with:
- lung problems (eg asthma, chronic bronchitis, and / or chronic obstructive pulmonary disease )
- severe heart problems (eg heart failure, irregular heartbeat )
- problems with the gallbladder or bile ducts (eg gallstones )
- problems with the stomach or intestines (eg stomach ulcers )
- impaired or impaired mental or intellectual function (learning difficulties, difficulty remembering, perception difficulties, and difficulty solving problems) or mental problems
- kidney problems (eg kidney failure or kidney stones ) –
- eye problems (eg narrow-angle glaucoma ( glaucoma ))
If you sweat profusely
If you sweat profusely while taking Salagen, you should increase your fluid intake. If this does not help, consult a doctor as too little fluid intake can lead to dehydration and organ damage.
Children and young people
This medicine should not be given to children or adolescents under 18 years of age.
Other drugs and Salagen
Tell your doctor or pharmacist if you have recently taken, or might take any other medicines.
It is especially important to tell your doctor if you are taking the following medicines:
- beta-blockers (medicines to treat high blood pressure, heart problems, or eye problems)
- medicines for diarrhea (eg atropine)
- asthma medication (eg ipratropium for inhalation )
- medicines that activate the so-called parasympathetic nervous system (eg medicines for glaucoma, nervous system or mental illness, Alzheimer’s disease, or medicines used to speed up the emptying of the gastrointestinal tract)
- drugs that are broken down by the liver enzyme called CYP2A6, e.g. blood pressure-lowering drug irbesartan and medicines to prevent blood clots ( warfarin, dicumarol)
Talk to your doctor or pharmacist if you are unsure if any of your medicines belong to this list.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before using this medicine.
Pregnancy
Do not use Salagen during pregnancy without your doctor’s recommendation. If you are a woman of childbearing potential, you should use an effective contraceptive while you are taking this medicine. Consult your doctor.
Breast-feeding
It is not known if pilocarpine is transferred to breast milk. Your doctor will tell you if you should stop using Salagen or stop breastfeeding.
Fertility
This medicine may affect male and female fertility. If you are planning to have a baby, ask your doctor for advice before taking this medicine.
Driving and using machines
Salage can cause dizziness or affect vision, in particular, you may have trouble seeing well in the dark. If this happens, you shouldn’t drive or use any tools or machines.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
How to use Salagen
Always use this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
The recommended dose is:
- For patients who have received radiation therapy for head or neck cancer: The recommended starting dose for adults is 1 tablet (5 mg) three times a day. Remember to take the last tablet of the day with the evening meal.
- For patients with Sjögren’s syndrome: The recommended dose for adults is 1 tablet (5 mg) four times a day. Remember to take the last tablet just before going to bed.
Depending on how you respond to treatment, your doctor may suggest a higher or lower dose. Dose one can be increased up to 30 mg (6 tablets) a day.
For patients with hepatic impairment:
If you have cirrhosis (liver disease), your doctor will start your treatment with a lower daily dose. Depending on how you respond to treatment, your doctor may gradually increase your dose up to the recommended daily dose.
How to take the medicine
The tablets should be taken by mouth. Take each Salagen tablet with a glass of water during or immediately after the meal. Try to take the tablets at regular intervals throughout the day, e.g. take the first tablet in the morning, the second in the afternoon, and the third in the evening.
Duration of treatment
Your doctor will tell you exactly how long you should take the tablets. If no improvement is noticed after 2-3 months of treatment, the doctor may decide to discontinue treatment.
If you have used too much Salagen
If you have ingested too much medicine or if e.g. a child ingested the medicine by mistake, contact a doctor or hospital for risk assessment and advice. You may need medical care or even an emergency hospitalization.
Symptoms of overdose may include stomach cramps, diarrhea, nausea, vomiting, involuntary emptying of stools and urination, sweating, salivation, increased mucus secretion from the lungs, contraction of the pupil of the eye, and low heart rate, low blood pressure, cramps or general twitching of muscles.
If you have forgotten to use Salagen
Do not take a double dose to make up for a forgotten tablet.
If you stop taking Salagen
Do not stop treatment without your doctor’s recommendation.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
POSSIBLE SIDE EFFECTS
Like all medicines, Salagen can cause side effects, although not everybody gets them.
Very common side effects (affects more than 1 patient in 10):
- flu-like symptoms
- sweating
- headache
- need for more frequent urination
Common side effects (affects 1 to 10 patients in 100):
- feeling weak
- overindulge
- Runny nose
- allergic reactions including rash and itching
- dizziness (may occur more frequently in patients over 65 years of age)
- diarrhea, constipation
- digestive problems; abdominal pain; nausea; vomiting
- increased salivation
- sudden reddening of the skin; high blood pressure
- palpitations (the feeling that the heart is beating faster, harder, or arrhythmically)
- watery eyes, blurred vision or blurred vision, red and swollen eyes ( inflammation of the conjunctiva ), eye pain
Uncommon side effects (affects 1 to 10 patients in 1,000):
- increased need to urinate
- gas problems.
The following side effects due to the action of the active substance may also occur:
- respiratory distress
- stomach cramps
- changes in heart function including low heart rate ( bradycardia ), fast-beating heart ( tachycardia ), irregular heart rhythm ( arrhythmia ), disorders of the heart’s conduction system that prevent the heart from beating normally (atrioventricular block)
- low blood pressure
- tremors
- changes in the mental state including memory disorders, hallucinations (you see and hear things that are not real), mood swings, restlessness, and confusion
How the Salage is to be stored
Keep out of sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton after “EXP”. The expiration date is the last day of the specified month.
Do not store above 25 ° C.
Store in the original package. Sensitive to light. Moisture sensitive.
Do not use Salagen if the packaging is defective or damaged.
The medicine 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.
Contents of the packaging and other information
Content declaration
- The active substance is pilocarpine hydrochloride. One tablet contains 5 mg pilocarpine hydrochloride.
- The other ingredients are microcrystalline cellulose and stearic acid. Film coating: Opadry white, OY-7300 (containing hypromellose, macrogol 400, titanium dioxide (E 171)), and carnauba wax.
What the medicine looks like and the contents of the pack
Each tablet is round, cupped, and white and marked with “SAL” on one side and “5 mg” on the other.
The tablets are packaged in blisters. One carton contains 14, 21, 28, or 84 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Merus Labs Luxco SaRL
26-28 rue Edward Steichen
L-2540 Luxembourg.
Manufacturer responsible for the release of a batch
Norgine BV
Antonio Vivaldi Street 150
1083 HP Amsterdam,
Netherlands