Moxonidine 300 Microgram Tablets
PACKAGE LEAFLET: INFORMATION FORTHE USER
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Moxonidine 200 microgram Film-coated Tablets Moxonidine 300 microgram Film-coated Tablets Moxonidine 400 microgram Film-coated Tablets
Active substance: moxonidine
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 gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Moxonidine is and what it is used for
2. Before you take Moxonidine
3. How to take Moxonidine
4. Possible side effects
5. How to store Moxonidine
6. Further information
1 What Moxonidine is and what it is used for
2 Before you take Moxonidine
Do not take Moxonidine mg if you are/have
• allergic (hypersensitive) to moxonidine or any of the other ingredients
• previously had painful skin swelling for several days (angioneurotic oedema)
• certain heart stimulus disorders known as
- sick sinus syndrome
- sinoatrial block
- AV block 2nd and 3rd degree
• a pulse of less than 50 beats per minute at rest
• a dangerous irregular or abnormal heart rate
• heart failure
• severe heart circulation problems or new or increasing chest complaints induced by these (unstable angina pectoris)
• a severely lowered hepatic function
• a severely lowered kidney function.
Take special care with Moxonidine
Due to limited knowledge, your doctor will only prescribe you Moxonidine in the following cases if strictly indicated:
• Parkinson's disease
• epilepsy
• increased eye pressure
• depression
• a slightly lowered kidney function - see also section 3.
• lowered fluid circulation in the brain
• recent heart attack
• lowered fluid circulation to the legs or arms such as Raynaud's syndrome or in patients with grammy leg
• if taking other medicines - see below!
• pregnancy and lactation
Tell your doctor if any of the above conditions concerns you.
Children and adolescents of less than 16 years
Due to insufficient knowledge, Moxonidine should not be used by children and adolescents under 16 years.
Elderly people, over 65 years
There is no need to reduce the dose of Moxonidine in elderly patients.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
• Medicines to treat high blood pressure
The blood pressure-lowering effect of moxonidine may be enhanced.
If Moxonidine is combined with beta-blockers and treatment must be discontinued: the beta-blocker must be discontinued first followed by Moxonidine some days later.
• Soporifics, tranquillizers and sedatives
Moxonidine may increase the effect of these medicines. The depressant effect of benzodiazepines, which are soporifics and tranquillizers may be enhanced after simultaneous Moxonidine use.
• Medicines, which dilate blood vessels such as tolazoline
Tolazoline may depending on dose, lessen the effect of moxonidine.
• Special medicines used to treat depression, such as amitriptyline (tricyclic antidepressants)
Avoid using simultaneously with Moxonidine, as insufficient data is available.
Taking Moxonidine with food and drink
You should not consume any alcohol during treatment with Moxonidine.
Pregnancy and breast-feeding
• Only take Moxonidine during pregnancy if your doctor indicates that it is absolutely necessary, as insufficient data is available.
• Moxonidine should not be used if you are breast-feeding,
as it passes into mother's milk.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Drowsiness and dizziness may occur when taking Moxonidine. If your attention is decreased, do not drive or operate machines.
Important information about some of the ingredients of Moxonidine
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
How to take Moxonidine
Always take Moxonidine exactly as your doctor has told you.You should check with your doctor or pharmacist if you are not sure.
The usual dose is
• Starting dose: 1 tablet every morning
• Dosage adjustment
If necessary your doctor can increase the dosage to 2 tablets after a 3 week interval. These 2 tablets may be taken as single dose or divided into 1 tablet in the morning and 1 tablet in the evening.
In case of insufficient response after a further 3 week treatment, the dosage may be increased to a maximum of 3 tablets. However, this dose must be divided into one dose in the morning and a second in the evening.
• Maximum dose
The maximum dose is 3 tablets per day.
However, do not take more than 2 tablets together.
• Patients with mild lowered kidney function
In this case a single dose of 1 tablet and a daily dose of 2 tablets must not be exceeded.
• Duration of use
Your attending doctor decides the duration of use.
• Stopping treatment
Sudden Moxonidine discontinuation is not recommended. If your doctor stops the therapy, he will gradually discontinue the tablets over a period of 2 week period.
Please take Moxonidine tablets orally, unchewed and with a glass of water. You may take the tablets prior to, with or after meals.
If you take more Moxonidine than you should
If you overdose, please contact your doctor immediately who will decide on further measures.
• dry itching or burning sensation in the eye
If you observe signs of the above described side effects, please inform your attending doctor.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
How to store Moxonidine
Keep out of the reach and sight of children.
These symptoms must be expected following an overdose:
• sedation
• increased fall in blood pressure
• circulatory complaints such as unconsciousness when changing from lying to standing
• lowered heart beat
• dry mouth
• vomiting and a contradictory rise in blood pressure may occur in rare cases.
If you forget to take Moxonidine
Take the missed dose as soon as you remember, unless it is almost time for your next dose. In that case follow your usual schedule.
Never take a double dose of Moxonidine to make up for a forgotten dose.
If you stop taking Moxonidine
Do not terminate treatment without consulting your doctor, as abrupt Moxonidine discontinuation may increase your blood pressure.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Do not use the medicinal product after the expiry date which is stated on the blister and carton. The expiry date refers to the last day of that month.
Do not store above 30°C.
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, Moxonidine can cause side effects, although not everybody gets them.
The following side effects may commonly occur, particularly at the beginning of treatment:
• dry mouth
• headache
• weakness
• dizziness
Frequency and severity of these symptoms often subside in the course of treatment.
Side effects can occur with the following frequencies:
What Moxonidine contains
The active substance is moxonidine.
Each film-coated tablet contains 0.2 mg, 0.3 mg or 0.4 mg moxonidine.
The other ingredients are: crospovidone, hypromellose, lactose monohydrate, macrogol 400, magnesium stearate (Ph.Eur.), povidone K25, colouring agents red iron oxide (E 172), titanium dioxide (E 171).
What Moxonidine looks like and contents of the pack
Moxonidine Tablets are round, Moxonidine 0.2 mg Tablets are light pink, Moxonidine 0.3 mg Tablets are pink and Moxonidine 0.4 mg Tablets are dark pink.
Moxonidine is available in packs containing 10, 20, 28, 30, 50, 98, 100, 400 (20x20, 10x40 only as hospital pack) film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Sandoz Ltd,
Frimley Business Park, Frimley,
Camberley, Surrey, GU16 7SR, UK.
Very common, occurs in more than 10 users
• drowsiness
• headache
• dizziness
• sleepiness
• dry mouth
Common, occurs in 1 to 10 per 100 users
• distorted thoughts
• sleep disturbances
• nausea
• constipation and other bowel or stomach disorders
• weakness
• dilated blood vessels
Uncommon, occurs in 1 to 10 per 1000 users
• depression
• anxiety
• sedation
• allergic skin reactions
• fluid accumulation in various body regions
• painful skin swelling lasting some days
• fall in blood pressure even with dizziness when changing position
• sudden unconsciousness
• sensation of prickling, itching or tingling at extremities without there being any cause
• general fluid increase in the body
• anorexia
• pain in the large salivary glands, which are in front of each ear
• circulatory problems of hands and feet (Raynaud's syndrome)
• cramping leg pain due to circulatory problems in the leg arteries (claudication intermittens)
• enlargement of the male breast gland
• impotence and loss of libido
• urinary retention or incontinence
or
Salutas Pharma GmbH Otto-von-Guericke-Allee 1 D-39179 Barleben Germany
This leaflet was last approved in 11/2010 (to be amended after approval).
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