SALAGEN 5 mg Tabletki Powlekane
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Treść ulotki
Salagen
5 mg film-coated tablets
Pilocarpine hydrochloride
Read this leaflet carefully before taking this medicine as it contains
important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
- If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
Contents of this leaflet:
- 1. What Salagen is and what it is used for
- 2. What you need to know before you take Salagen
- 3. How to take Salagen
- 4. Possible side effects
- 5. How to store Salagen
- 6. Contents of the pack and other information
1. What Salagen is and what it is used for
Salagen contains pilocarpine hydrochloride as the active ingredient, which belongs to a group of
medicines called parasympathomimetic or cholinergic agents.
Salagen stimulates certain nerves and glands in your body. After taking Salagen your body
will produce more saliva, tears, sweat, gastric juices and mucus.
Salagen is used
- If you have been treated with radiotherapy for cancer of the head or neck and your mouth feels very dry,
- If you have been diagnosed with a condition called Sjögren's syndrome and your mouth and/or eyes are dry and itchy.
If you have any questions about how Salagen works or why it has been prescribed to you
ask your doctor.
2. What you need to know before taking Salagen
Do not take Salagen
- If you are allergic (hypersensitive) to pilocarpine hydrochloride or any of the excipients of Salagen (listed in section 6).
- If you suffer from untreated asthma
- If you suffer from untreated heart or kidney diseases
- If you have chronic diseases treated with medicines that act like Salagen
- If you have inflammation of the iris of the eye (iritis).
If you are in any of these conditions, contact your doctor before taking Salagen
Warnings and precautions
Consult your doctor or pharmacist before taking Salagen.
Contact your doctor before taking Salagen if you have:
- lung problems (e.g. asthma, chronic bronchitis and/or chronic obstructive pulmonary disease).
- Heart problems (e.g. heart failure, irregular pulse).
- Problems with the gallbladder (e.g. gallstones).
- Stomach problems (e.g. ulcers).
- Liver problems (e.g. impaired liver function).
- Problems with the nervous system/mental problems.
- Kidney problems (e.g. kidney failure or kidney stones).
- Eye problems (e.g. closed-angle glaucoma).
Eye check
Your doctor may want to check your eyes before starting therapy. If you haven't had your eyes
checked recently, tell your doctor.
Excessive sweating
If you sweat excessively during treatment with Salagen, drink more fluids. If this does not help,
contact your doctor because if the situation persists you may suffer from dehydration and damage to the
organs.
Other medicines and Salagen
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine.
It is particularly important that you inform your doctor if you are taking any medicine for the
treatment of:
- hypertension, heart problems or eye problems (e.g. a beta blocker).
- diarrhea (e.g. atropine)
- asthma (e.g. ipratropium inhalations).
Pregnancy, breastfeeding and fertility
Pregnancy
Do not take Salagen during pregnancy unless your doctor has recommended it. If
you are pregnant or think you might be, tell your doctor before taking Salagen.
Breastfeeding
Do not take Salagen if you are breastfeeding.
Ask your doctor for advice before taking any medicine
Male fertility
If you are planning to conceive a child, ask your doctor for advice before taking this
medicine.
Driving and operating machinery
Salagen can cause dizziness or affect vision, in particular, you may have difficulty
seeing well at night. If this happens, do not drive and do not use tools or machinery.
3. How to take Salagen
Always take Salagen exactly as your doctor has told you. If you have any doubts, ask your doctor or pharmacist.
The recommended dose is:
- For patients who have been treated with radiotherapy for head or neck cancer: The recommended dose for adults is one 5 mg tablet three times a day. Make sure to take the last tablet of the day with the evening meal.
- For patients diagnosed with Sjögren's syndrome:The recommended dose for adults is one 5 mg tablet four times a day. Make sure to take the last tablet of the day just before going to bed.
- For patients with impaired liver function:If you have cirrhosis (liver disease), your doctor will start you on a lower daily dose. Depending on how you respond to treatment, your doctor may gradually increase your dose up to the recommended daily dose.
Depending on how you respond to treatment, your doctor may suggest a higher or lower dose.
The dose can be increased up to 30 mg (6 tablets) per day.
Your doctor will tell you exactly how long you should take the tablets. If you do not notice
improvements after 2 or 3 months, your doctor may decide to stop the therapy.
Salagen must be taken by mouth. Do not chew or bite the tablets. Take the tablets
of Salagen with a glass of water, during or immediately after meals.
Try to take the tablets at regular intervals throughout the day, for example, take the first tablet in the morning, one in the afternoon and one in the evening.
Elderly people (65 years and over)
There are no specific dose recommendations for patients 65 years and over.
Use in children and adolescents (2 to 17 years)
The safety of Salagen has not been established in children and adolescents.
If you take more Salagen than you should
If you accidentally take too many Salagen tablets, talk to your doctor immediately.
You may need medical attention.
If you forget to take Salagen
If less than 6 hours have passed since you took your last tablet, take it with food when you remember. Then delay taking the next tablet by at least 3 or 4
hours from the usual time.
If more than 6 hours have passed since you took your last tablet and you are due to take the next one,
take only one. This means you will have taken one tablet less than your usual daily dose. Do not take a double dose to make up for a missed tablet.
If you stop taking Salagen
Stopping treatment with Salagen may worsen your symptoms. Do not
stop treatment unless your doctor tells you to.
If you have any questions about using Salagen, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Salagen can cause side effects, although not everybody gets them.
manifest.
Very common side effects (may affect more than 1 in 10 people):
- Flu-like symptoms
- Sweating
- Headache
- Need to urinate more frequently
Common side effects (may affect up to 1 in 10 people):
- Fatigue
- Chills
- Runny nose
- Allergic reactions including rash and itching
- Dizziness
- Diarrhoea; constipation
- Indigestion; abdominal pain; nausea; vomiting
- Increased salivation
- Flushing (increased blood pressure)
- Palpitations (increased heartbeats))
- Tearing; altered vision; red, swollen and painful eyes
Uncommon side effects (may affect up to 1 in 1,000 people):
- Urgent need to urinate
- Flatulence
Other side effects of the active ingredient pilocarpine hydrochloride:
- Difficulty breathing
- Severe stomach or abdominal pain
- Changes in heart rate and rhythm
- Decreases in blood pressure; fainting
- Tremors
- Changes in mental state including memory problems, mood swings and confusion
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the national reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Salagen
Keep this medicine out of the sight and reach of children.
Do not use Salagen after the expiry date which is stated on the pack after EXP. The expiry
date refers to the last day of the month.
Do not store at a temperature above 25°C.
Keep in the original packaging and carton in order to protect the medicine from
light and moisture.
Do not use Salagen if you notice that the pack is damaged or shows visible signs of deterioration.
Medicines should not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines you no longer use. This will help to protect
the environment.
6. Contents of the pack and other information
What Salagen contains
- The active ingredient is pilocarpine hydrochloride. Each film-coated Salagen 5 mg tablet contains 5 mg of pilocarpine hydrochloride.
- The excipients are microcrystalline cellulose and stearic acid. The coating consists of Opadry White, OY-7300 (containing hypromellose, macrogol 400, titanium dioxide [E171]) and carnauba wax.
Description of the appearance of Salagen and contents of the pack
Salagen tablets for oral use are white, round and biconvex, with “SAL” imprinted on
one side and “5 ” on the other.
The tablets are packaged in blisters supplied in cartons containing 14, 21, 28 or 84 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Merus Labs Luxco II S.à R.L.
26-28, rue Edward Steichen,
L-2540, Luxembourg
Manufacturing site (batch release):
Merus Labs Netherlands B.V.
Alexander Battalaan 37
Maastricht, 6221 CB
Netherlands
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- Kraj rejestracji
- Postać farmaceutycznaCoated tablet, 5 MG
- Kod ATCN07AX01
- Substancja czynna
- Wymaga receptyTak
- Producent
- Te treści mają charakter wyłącznie informacyjny i nie zastępują konsultacji lekarskiej.
- Zamienniki SALAJENPostać farmaceutyczna: Injectable solution, 1 G/4 MLSubstancja czynna: choline alfoscerateProducent: NEOPHARMED GENTILI S.P.A.Wymaga receptyPostać farmaceutyczna: Capsule, 400 MGSubstancja czynna: choline alfoscerateProducent: ITALFARMACO S.P.A.Wymaga receptyPostać farmaceutyczna: Coated tablet, 20 MG/40 MGSubstancja czynna: cinnarizine, combinationsProducent: FARMA GROUP S.R.L.Wymaga recepty
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SALAJEN wymaga recepty w Włochy. Możesz skonsultować się z lekarzem online, aby sprawdzić, czy ten lek może być odpowiedni w Twojej sytuacji.
Substancją czynną w SALAJEN jest pilocarpine. Informacja ta pomaga rozpoznać leki o tym samym składzie, ale pod różnymi nazwami handlowymi.
SALAJEN jest produkowany przez Merus Labs Luxco II S.a.r.l.. Nazwy handlowe i opakowania mogą się różnić w zależności od dystrybutora.
Lekarze, tacy jak Lekarze rodzinni, Psychiatrzy, Dermatolodzy, Kardiolodzy, Endokrynolodzy, Gastroenterolodzy, Pulmonolodzy, Nefrolodzy, Reumatolodzy, Hematolodzy, Zakaźnicy, Alergolodzy, Geriatrzy, Pediatrzy, Onkolodzy, mogą ocenić, czy stosowanie SALAJEN jest odpowiednie w Twoim przypadku, w zależności od sytuacji klinicznej i lokalnych przepisów. Możesz umówić konsultację online, aby omówić objawy i możliwe dalsze kroki.
Polska posiada dobrze rozwiniętą infrastrukturę ochrony zdrowia w dużych miastach, takich jak Warszawa, Kraków, Wrocław i Gdańsk. Apteki są łatwo dostępne i działają zgodnie z obowiązującymi przepisami, zapewniając dostęp do leków na receptę.
Możesz kupić SALAJEN w Warszawie, Krakowie, Wrocławiu lub Gdańsku w każdej aptece, posiadając ważną receptę.
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Inne leki zawierające tę samą substancję czynną (pilocarpine) to m.in. DELEKIT, LYATILIN, AJIVERT. Mogą one różnić się nazwą handlową lub postacią, ale zawierają ten sam składnik terapeutyczny. Przed zmianą lub rozpoczęciem nowego leku skonsultuj się z lekarzem.
