Telinod Tablets

TELINOD tablets contain two active substances called telmisartan and amlodipine. TELINOD is used to treat high blood pressure (also known as essential hypertension) in patients using the same components as individual components, or when treatment with amlodipine alone did not lower your blood pressure enough.

Do not take TELINOD:

• if you are hypersensitive (allergic) to telmisartan or amlodipine or to any of the other ingredients of TELINOD (listed in section 6)
• if you are allergic to other medicines of the dihydropyridine type (one type of calcium channel blocker)
• if you have developed swelling and giant wheals on your skin when having previously taken medicines called angiotensin converting enzyme inhibitors (ACE inhibitors) or angiotensin receptor blockers (ARBs)
• Do not take TELINOD if you are pregnant, are considering becoming pregnant or are breastfeeding. A switch to a suitable alternative treatment should be carried out in advance of planned pregnancy.
• if you have an inherited disorder or of unknown origin you suffer from recurrent episodes of the accumulation of fluids outside of the blood vessels, blocking the normal flow of blood or lymphatic fluid and causing rapid swelling of tissues in the hands, feet, limbs, face, intestinal tract, or airway (hereditary or idiopathic angioedema)
• if you have a heart condition called hypertrophic obstructive cardiomyopathy
• if you suffer from severe renal impairment
• if both blood vessels to the kidneys are narrowed or if you have a single kidney and the blood vessel to the kidney is narrowed
• if you have narrowing of the aortic heart valve (aortic stenosis) or cardiogenic shock (a condition)
• if you are currently taking lithium or potassium sparing water tablets containing spironolactone, triamterene or amiloride
• if you suffer from porphyria
• if you are currently taking aliskiren-containing medicines
• if you suffer from biliary obstruction (a problem with the drainage of the bile from the liver and gall bladder)
• if you suffer from severe liver problems
• if you suffer from severe low blood pressure (hypotension)
• if your heart cannot pump enough blood and oxygen to the brain and other vital organs (cardiac shock)
• if you have a blockage of the outflow of the left side of the heart
• if the blood circulation to your heart has not fully recovered following a recent heart attack
• if you have to use fluoroquinolones (antibiotic) concomitantly with TELINOD and you have moderate to severe renal impairment or if you are elderly.

Warnings and precautions

If you should become pregnant while taking TELINOD, the treatment should be stopped promptly and you should be switched to a different class of antihypertensive treatment.

Take special care with TELINOD:

• if you suffer from liver problems
• if you suffer from kidney disease or have ever had a kidney transplant
• if you have low blood pressure (hypotension), which is likely to occur if you are dehydrated (excessive loss of body water) or have salt deficiency due to diuretic therapy (“water tablets”), low-salt diet, diarrhoea, or vomiting
• if you have heart failure and kidney problems affecting the renin-angiotensin-aldosterone system
• if you are treated with TELINOD and a fluoroquinolone antibiotic (see section 4.3)
• if you have been told that you have raised aldosterone levels (water and salt retention in the body along with imbalance of various blood minerals)
• if the valve of your heart is narrowed (aortic and mitral valve stenosis) or your heart muscle is enlarged (hypertrophic obstructive cardiomyopathy)
• if you have heart - associated chest pain also at rest or with minimal effort (unstable angina pectoris)
• if you have heart failure
• if you have high potassium levels in your blood or use salt substitutes that contain potassium
• if you have diabetes
• if you are elderly and your dose needs to be increased

Children and adolescents

Do not give TELINOD to children under the age of 18 years.

Other medicines and TELINOD

Always tell your healthcare provider if you are taking any other medicine. (This includes all complementary or traditional medicines.)

Tell your doctor if you are taking:

• Other antihypertensive medicines
• Medicines with the potential to lower blood pressure (baclofen, amifostine, barbiturates, narcotics or antidepressants or alcohol
• Corticosteroids
• Medicines that may increase blood potassium levels such as salt substitutes containing potassium, potassium-sparing diuretics (certain ‘water tablets’)
• Lithium-containing medicines to treat some types of depression
• ACE-inhibitors, angiotensin II receptor antagonists or aliskiren (see Do not take TELINOD and Take special care with TELINOD)
• NSAIDs (non-steroidal anti-inflammatory medicines, e.g. acetylsalicylic acid or ibuprofen), heparin
• Fluoroquinolones (Antibiotic)
• Digoxin (a heart medication)
• Grapefruit and grapefruit juice
• Ketoconazole (Treatment of fungal infections)
• Erythromycin, clarithromycin (Antibiotic)
• Verapamil or diltiazem (Used to lower blood pressure)
• Rifampicin (Antibiotic)
• St. John’s wort ( Hypericum perforatum )
• Dantrolene infusion used to treat an anaesthetic complication called malignant hyperthermia
• Ciclosporin, tacrolimus, sirolimus, temsirolimus or everolimus used to suppress your immune system or to treat certain types of cancer
• Simvastatin (Used to lower cholesterol)

TELINOD with food and drink

You can take TELINOD with or without food. You should not eat grapefruit or drink grapefruit juice when you take TELINOD because this can increase the blood pressure lowering effect in some people.

Do not take TELINOD with alcohol.

Pregnancy, breastfeeding and fertility

Do not take TELINOD and consult your doctor, pharmacist or other healthcare provider for advice if you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby. A switch to a suitable alternative treatment should be carried out in advance of planned pregnancy.

Do not share medicines prescribed for you with any other person. Always take TELINOD exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. The usual dose is one tablet a day. Your doctor will start you on the lowest dose, 40/5 mg and will increase the dose if necessary. Try to take the tablet at the same time each day. You can take TELINOD with or without food. If your liver is not working properly, the usual dose should not exceed one 40 mg/5 mg tablet or one 40 mg/10 mg tablet per day. Your doctor will tell you how long your treatment with TELINOD will last. If you have the impression that the effect of TELINOD is too strong or too weak, talk to your doctor or pharmacist.

If you take more TELINOD than you should

In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison centre.

If you forget to take TELINOD

If you forget to take a dose, take it as soon as you remember unless it is nearly time for your next dose. Do not take a double dose to make up for forgotten individual doses.

TELINOD can have side effects. Not all side effects reported for TELINOD are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking TELINOD, please consult your healthcare provider for advice. If any of the following symptoms occur, stop taking the TELINOD and tell your doctor immediately or go to the casualty department at your nearest hospital:

• swelling of the hands, feet, ankles, face, lips, mouth or throat, which may cause difficulty in swallowing or breathing,
• rash or itching,
• fainting,
• yellowing of the skin and eyes, also called jaundice.

These are all very serious side effects. If you have them, you may have had a serious allergic reaction to TELINOD. You may need urgent medical attention or hospitalisation.

Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

• sepsis (often called "blood poisoning", is a severe infection of the whole-body with high fever and the feeling of being severely ill)
• severe allergic reactions with blistering eruptions of the skin and mucous membranes (exfoliative dermatitis, Stevens-Johnson-Syndrome).

These are all serious side effects. You may need urgent medical attention.

Tell your doctor if you notice any of the following:

Fixed dose combination

Frequent side effects

• dizziness
• swelling in your lower legs and hands

Less frequent side effects

• bladder inflammation
• depression, feeling anxious, sleeplessness
• fainting, sleepiness, migraine, headache
• tingling or numbness of the hands or feet
• weakness, numbness from nerve damage in the hands or feet
• taste disorder, tremors
• feeling of spinning
• palpitations (awareness of your heartbeat), slow heartbeat
• low blood pressure, dizziness on standing up
• flushing
• cough
• stomach pain, diarrhoea, being sick (vomiting), feeling sick (nausea)
• indigestion, dry mouth, overgrowth of gum tissue around the teeth
• eczema (a skin disorder), redness of skin, rash
• joint stiffness, back pain, pain in arms and legs, muscle spasms, muscle aches and pain
• urge to urinate during the night
• inability to obtain an erection
• chest pain, excess of watery fluid collecting in the cavities or tissues of the body
• weakness, tiredness, feeling unwell (malaise)
• increased liver enzymes, increased levels of uric acid in the blood

Telmisartan component of TELINOD:

Less frequent side effects

• urinary tract infections, upper respiratory tract infections (e.g., sore throat, inflamed sinuses, common cold), bladder inflammation
• low platelet count (thrombocytopenia)
• deficiency in red blood cells (anaemia)
• increase in certain white blood cells (eosinophilia)
• high potassium levels in blood, low blood sugar levels
• depression, anxiety, sleeplessness
• fainting
• visual disturbance
• feeling of spinning
• slow or fast heartbeat
• low blood pressure, dizziness on standing up
• difficulty breathing
• stomach pain, diarrhoea, being sick (vomiting), indigestion, dry mouth, flatulence, upset stomach
• abnormal liver function, liver disorder
• skin rash caused by a medicine
• hives, eczema (a skin condition), redness of skin, rash
• increased sweating
• joint stiffness, back pain, pain in arms and legs, inflammation of the tendons, muscle spasms, muscle aches and pain
• kidney impairment
• chest pain, weakness, flu-like illness (for example muscle pain, feeling generally unwell)
• increase liver enzymes, increased levels of creatinine, increased levels of creatinine phosphokinase in the blood, decreased haemoglobin (a blood protein), increased blood uric acid.

Amlodipine component of TELINOD:

Frequent side effects

• sleepiness, dizziness
• headache
• impaired vision, double vision
• quivering or irregular heartbeat
• flushing
• difficulty breathing
• stomach pain, diarrhoea, indigestion, constipation, (feeling sick) nausea, change of bowel habit
• joint swelling, cramps in legs
• excess of watery fluid collecting in the cavities or tissues of the body, weakness, tiredness

Less frequent side effects

• reduced number of white blood cells (leukopenia), low platelet count
• (thrombocytopenia)
• high blood sugar levels
• depression, anxiety, confusional state, sleeplessness, altered mood
• fainting
• muscle overactivity, numbness from nerve damage in the hands or feet, pins and needles sensation
• numbness, taste disorder, tremors
• ringing in the ears
• heart attack, irregular and often abnormally fast heart rate
• slow heart rate
• low blood pressure
• inflammation of the blood vessels
• cough, runny nose
• inflamed pancreas, inflammation of the stomach lining (gastritis), being sick (vomiting), overgrowth of gum tissue around the teeth, dry mouth
• inflammation of the liver (hepatitis), yellow skin caused by the build-up of bilirubin in the blood, increased levels of hepatic enzymes
• a skin disorder characterised by bull's-eye-shaped lesions.
• increased sensitivity of the skin to sun, hives
• skin rash, hair loss, purple-coloured spots and patches on the skin, skin discolouration, increased sweating
• joint stiffness, back pain, muscle aches and pain
• urge to urinate during the night, difficulty passing urine, frequent daytime urination
• inability to obtain an erection, enlarging of male breasts
• chest pain, pain
• feeling unwell (malaise)
• increased weight, decreased weight.

Side effects with unknown frequency

• involuntary or uncontrollable movements. tremors, muscle contractions, toxic epidermal necrolysis – a life-threatening skin disorder characterised by a blistering and peeling of the skin

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects

If you get side effects, talk to your doctor, pharmacist or nurse. You can also report side effects to SAHPRA via the Med Safety APP (Medsafety X SAHPRA) and eReporting platform (who-umc.org) found on SAHPRA website. By reporting side effects, you can help provide more information on the safety of TELINOD.

Store all medicines out of reach of children. Store at or below 30 °C. Store in the original package until required to use. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g., toilets).