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AstraZeneca

PritorPlus
telmisartan, hydrochlorothiazide

Package leaflet: Information for the user


PritorPlus 40 mg/12.5 mg tablets

telmisartan/hydrochlorothiazide


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


PritorPlus may increase the blood pressure lowering effect of other medicines used to treat high blood pressure or of medicines with blood pressure lowering potential (e.g. baclofen, amifostine). Furthermore, low blood pressure may be aggravated by alcohol, barbiturates, narcotics or antidepressants. You may notice this as dizziness when standing up. You should consult with your doctor if you need to adjust the dose of your other medicine while taking PritorPlus.


The effect of PritorPlus may be reduced when you take NSAIDs (non steroidal anti-inflammatory medicines, e.g. aspirin or ibuprofen).


PritorPlus with food and alcohol

You can take PritorPlus with or without food.

Avoid taking alcohol until you have talked to your doctor. Alcohol may make your blood pressure fall more and/or increase the risk of you becoming dizzy or feeling faint.

Pregnancy and breast-feeding

Pregnancy

You must tell your doctor if you think you are (ormightbecome) pregnant. Your doctor will normally advise you to stop taking PritorPlus before you become pregnant or as soon as you know you are

pregnant and will advise you to take another medicine instead of PritorPlus. PritorPlus is not

recommended during pregnancy, and must not be taken when more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy.


Breast-feeding

Tell your doctor if you are breast-feeding or about to start breast-feeding. PritorPlus is not recommended for mothers who are breast-feeding, and your doctor may choose another treatment for

you if you wish to breast-feed.


Driving and using machines

Some people feel dizzy or tired when taking PritorPlus. If you feel dizzy or tired, do not drive or

operate machinery.


PritorPlus contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium- free’.


PritorPlus contains milk sugar (lactose)

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor

before taking this medicine.


PritorPlus contains sorbitol

This medicine contains 169 mg sorbitol in each tablet.


  1. How to take PritorPlus


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


    The recommended dose is one tablet a day. Try to take a tablet at the same time each day. You can take PritorPlus with or without food. The tablets should be swallowed with some water or other non- alcoholic drink. It is important that you take PritorPlus every day until your doctor tells you otherwise.


    If your liver is not working properly, the usual dose should not exceed 40 mg/12.5 mg once a day.


    If you take more PritorPlus than you should

    If you accidentally take too many tablets you may experience symptoms such as low blood pressure and rapid heartbeat. Slow heartbeat, dizziness, vomiting, reduced kidney function including kidney

    failure, have also been reported. Due to the hydrochlorothiazide component, markedly low blood pressure and low blood levels of potassium can also happen, which may result in nausea, sleepiness and muscle cramps and/or irregular heartbeat associated with the concomitant use of medicines such

    as digitalis or certain anti-arrhythmic treatments. Contact your doctor, pharmacist, or your nearest hospital emergency department immediately.


    If you forget to take PritorPlus

    If you forget to take a dose, do not worry. Take it as soon as you remember then carry on as before. If

    you do not take your tablet on one day, take your normal dose on the next day. Do not take a double dose to make up for forgotten individual doses.


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

  2. Possible side effects


    Like all medicines, this medicine can cause side effects, although not everybody gets them.


    Some side effects can be serious and need immediate medical attention:


    You should see your doctor immediately if you experience any of the following symptoms:


    Sepsis* (often called "blood poisoning"), is a severe infection with whole-body inflammatory response, rapid swelling of the skin and mucosa (angioedema), blistering and peeling of the top layer of skin (toxic epidermal necrolysis); these side effects are rare (may affect up to 1 in 1,000 people) or of unknown frequency (toxic epidermal necrolysis) but are extremely serious and patients should stop taking the medicine and see their doctor immediately. If these effects are not treated they could be fatal. Increased incidence of sepsis has been observed with telmisartan only, however can not be ruled out for PritorPlus.


    Possible side effects of PritorPlus:


    Common side effects (may affect up to 1 in 10 people)

    Dizziness


    Uncommon side effects (may affect up to 1 in 100 people)

    Decreased blood potassium levels, anxiety, fainting (syncope), sensation of tingling, pins and needles

    (paraesthesia), feeling of spinning (vertigo), fast heart beat (tachycardia), heart rhythm disorders, low blood pressure, a sudden fall in blood pressure when you stand up, shortness of breath (dyspnoea), diarrhoea, dry mouth, flatulence, back pain, muscle spasm, muscle pain, erectile dysfunction (inability to get or keep an erection), chest pain, increased blood uric acid levels.


    Rare side effects (may affect up to 1 in 1,000 people)

    Inflammation of the lung (bronchitis), activation or worsening of systemic lupus erythematosus (a

    disease where the body’s immune system attacks the body, which causes joint pain, skin rashes and fever); sore throat, inflamed sinuses, feeling sad (depression), difficulty falling asleep (insomnia), impaired vision, difficulty breathing, abdominal pain, constipation, bloating (dyspepsia), feeling sick (vomiting), inflammation of the stomach (gastritis), abnormal liver function (Japanese patients are more likely to experience this side effect), redness of the skin (erythema), allergic reactions such as itching or rash, increased sweating, hives (urticaria), joint pain (arthralgia) and pain in extremities, muscle cramps, flu-like-illness, pain, low levels of sodium, increased levels of creatinine, hepatic enzymes or creatine phosphokinase in the blood.


    Adverse reactions reported with one of the individual components may be potential adverse reactions with PritorPlus, even if not observed in clinical trials with this product.


    Telmisartan

    In patients taking telmisartan alone the following additional side effects have been reported:


    Uncommon side effects (may affect up to 1 in 100 people)

    Upper respiratory tract infection (e.g. sore throat, inflamed sinuses, common cold), urinary tract

    infections, deficiency in red blood cells (anaemia), high potassium levels, slow heart rate (bradycardia), cough, kidney impairment including acute kidney failure, weakness.


    Rare side effects (may affect up to 1 in 1,000 people)

    Low platelet count (thrombocytopenia), increase in certain white blood cells (eosinophilia), serious

    allergic reaction (e.g. hypersensitivity, anaphylactic reaction, drug rash), low blood sugar levels (in diabetic patients), somnolence, upset stomach, eczema (a skin disorder), arthrosis, inflammation of the tendons, decreased haemoglobin (a blood protein).

    Very rare side effects (may affect up to 1 in 10,000 people)

    Progressive scarring of lung tissue (interstitial lung disease)**


    *The event may have happened by chance or could be related to a mechanism currently not known.


    **Cases of progressive scarring of lung tissue have been reported during intake of telmisartan. However, it is not known whether telmisartan was the cause.


    Hydrochlorothiazide

    In patients taking hydrochlorothiazide alone the following additional side effects have been reported:


    Common side effects (may affect up to 1 in 10 people)

    Feeling sick (nausea), low blood magnesium level.


    Rare side effects (may affect up to 1 in 1,000 people)

    Reduction in blood platelets, which increases risk of bleeding or bruising (small purple-red marks in

    skin or other tissue caused by bleeding), high blood calcium level, headache.


    Very rare side effects (may affect up to 1 in 10,000 people)

    Increased pH (disturbed acid-base balance) due to low blood chloride level.


    Not known (frequency cannot be estimated from the available data)

    Inflammation of the salivary gland, skin and lip cancer (non-melanoma skin cancer), decreases in the

    number (or even lack) of cells in the blood, including low red and white blood cell count, , serious allergic reactions (e.g. hypersensitivity, anaphylactic reaction), decreased or loss of appetite,

    restlessness, light-headedness, blurred or yellowing of vision, decrease in vision and eye pain (possible

    signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute myopia or acute-angle closure glaucoma), inflammation of blood vessels (vasculitis necrotising), inflamed pancreas, upset stomach, yellowing of the skin or eyes (jaundice), lupus-like syndrome (a condition mimicking a disease called systemic lupus erythematosus where the body’s immune system attacks the body); skin disorders such as inflamed blood vessels in the skin, increased sensitivity to sunlight, rash, redness of the skin, blistering of the lips, eyes or mouth, skin peeling, fever (possible signs of

    erythema multiforme) weakness, kidney inflammation or impaired kidney function, glucose in the urine (glycosuria), fever, impaired electrolyte balance, high blood cholesterol levels, decreased blood

    volume, increased blood levels of glucose, difficulties in controlling blood/ urine levels of glucose in patients with a diagnosis of diabetes mellitus, or fat in the blood.


    Reporting of side effects

    If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects

    image

    not listed in this leaflet. You can also report side effects directly via thenationalreportingsystem listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.


  3. How to store PritorPlus


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


    Do not use this medicine after the expiry date which is stated on the carton after “EXP”. The expiry date refers to the last day of that month.


    This medicine does not require any special temperature storage conditions. Store in the original package in order to protect from moisture. Remove your PritorPlus tablet from the blister only directly prior to intake.


    Occasionally, the outer layer of the blister pack separates from the inner layer between the blister pockets. You do not need to take any action if this happens.

    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.


  4. Contents of the pack and other information What PritorPlus contains

Each tablet contains 40 mg telmisartan and 12.5 mg hydrochlorothiazide.


What PritorPlus looks like and contents of the pack

PritorPlus 40 mg/12.5 mg tablets are red and white, oblong-shaped two-layer tablets engraved with the code number 'H4'.

PritorPlus is available in blisters packs containing 14, 28, 30, 56, 90 or 98 tablets, or unit dose blister

packs containing 28 x 1 tablets.


Not all pack sizes may be available in your country.


Marketing Authorisation Holder

Bayer AG

51368 Leverkusen Germany


Manufacturer

Bayer AG

Kaiser-Wilhelm-Allee 51368 Leverkusen

Germany

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.


België / Belgique / Belgien

Bayer SA-NV

Tél/Tel: +32-(0)2-535 63 11

България

Байер България ЕООД

Тел. +359 (0)2-424 72 80

Česká republika

Bayer s.r.o.

Tel: +420 266-101-111

Danmark

Bayer A/S

Tlf: +45-45 23 50 00

Deutschland

Bayer Vital GmbH

Tel: +49-(0)214-30 513 48

Eesti

Bayer OÜ

Tel: +372 655 85 65

Ελλάδα

Bayer Ελλάς ΑΒΕΕ

Τηλ: +30 210 618 75 00

España

Bayer Hispania S.L. Tel: +34-93-495 65 00

France

Bayer HealthCare

Tél (N° vert): +33-(0)800 87 54 54

Hrvatska

Bayer d.o.o.

Tel: + 385-(0)1-6599 900

Ireland

Bayer Limited

Tel: +353-1-216-3300

Ísland

Icepharma hf.

Sími: +354 540 8000

Italia

Bayer S.p.A.

Tel: +39-02-397 81

Κύπρος

NOVAGEM Limited

Τηλ: + 357 22 48 38 58

Latvija

SIA Bayer

Tel: +371 67 84 55 63

Lietuva

UAB Bayer

Tel. +37 05 23 36 868

Luxembourg / Luxemburg

Bayer SA-NV

Tél/Tel: +32-(0)2-535 63 11

Magyarország

Bayer Hungária Kft. Tel.:+36-14 87-41 00

Malta

Alfred Gera and Sons Ltd. Tel: +356-21 44 62 05

Nederland

Bayer B.V.

Tel: +31-(0)297-28 06 66

Norge

Bayer AS

Tlf. +47 23 13 05 00

Österreich

Bayer Austria Ges. m. b. H.

Tel: +43-(0)1-711 46-0

Polska

Bayer Sp. z o.o.

Tel.: +48-22-572 35 00

Portugal

Bayer Portugal Lda

Tel: +351-21-416 42 00

România

SC Bayer SRL

Tel.: +40 21 528 59 00

Slovenija

Bayer d. o. o.

Tel.: +386-1-58 14 400

Slovenská republika

Bayer, spol. s r.o.

Tel: +421 2 59 21 31 11

Suomi/Finland

Bayer Oy

Puh/Tel.: +358-20 785 21

Sverige

Bayer AB

Tel: +46-(0)8-580 223 00

United Kingdom (Northern Ireland)

Bayer AG

Tel: +44 (0) 118 206 30 00


This leaflet was last revised in {MM/YYYY}


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