Patient leaflet - Cinacalcet Abdi 90 mg film-coated tablets
1. What Cinacalcet Abdi is and what it is used for
Cinacalcet Abdi works by controlling the levels of parathyroid hormone (PTH), calcium and phosphorus in your body. It is used to treat problems with organs called parathyroid glands. The parathyroids are four small glands in the neck, near the thyroid gland, that produce parathyroid hormone (PTH).
Cinacalcet Abdi is used in adults:
- to treat secondary hyperparathyroidism in adults with serious kidney disease who need dialysis to clear their blood of waste products.
- to reduce high levels of calcium in the blood (hypercalcaemia) in adult patients with parathyroid cancer.
- to reduce high levels of calcium in the blood (hypercalcaemia) in adult patients with primary hyperparathyroidism when removal of the gland is not possible.
Cinacalcet Abdi is used in children aged 3 years to less than 18 years of age:
- to treat secondary hyperparathyroidism in patients with serious kidney disease who need dialysis to clear their blood of waste products, whose condition is not controlled with other treatments.
In primary and secondary hyperparathyroidism too much PTH is produced by the parathyroids glands. “Primary” means that the hyperparathyroidism is not caused by any other condition and “secondary” means that the hyperparathyroidism is caused by another condition, e.g., kidney disease. Both primary and secondary hyperparathyroidism can cause the loss of calcium in the bones, which can lead to bone pain and fractures, problems with blood and heart vessels, kidney stones, mental illness and coma.
2. What you need to know before you take Cinacalcet Abdi
Do not take Cinacalcet Abdi
- if you are allergic to cinacalcet or any of the other ingredients of this medicine (listed in section 6).
- if you have low levels of calcium in your blood. Your doctor will monitor your blood calcium levels.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Cinacalcet Abdi
Before you start taking Cinacalcet Abdi, tell your doctor if you have or have ever had:
- seizures (fits or convulsions). The risk of having seizures is higher if you have had them before;
- liver problems;
- heart failure.
Cinacalcet Abdi reduces calcium levels. Life threatening events and fatal outcomes associated with low calcium levels (hypocalcaemia) have been reported in adults and children treated with cinacalcet.
Please tell your doctor if you experience any of the following which may be signs of low calcium levels: spasms, twitches, or cramps in your muscles, or numbness or tingling in your fingers, toes or around your mouth or seizures, confusion or loss of consciousness while being treated with Cinacalcet Abdi.
Low calcium levels can have an effect on your heart rhythm. Tell your doctor if you experience an unusually fast or pounding heartbeat, if you have heart rhythm problems, or if you take medicines known to cause heart rhythm problems, while taking cinacalcet.
For additional information see section 4.
During treatment with Cinacalcet Abdi, tell your doctor:
- if you start or stop smoking, as this may affect the way cinacalcet works.
Children and adolescents
Children under the age of 18 with parathyroid cancer or primary hyperparathyroidism must not take Cinacalcet Abdi.
If you are being treated for secondary hyperparathyroidism, your doctor should monitor your calcium levels before starting treatment with Cinacalcet Abdi and during treatment with Cinacalcet Abdi. You should inform your doctor if you experience any of the signs of low calcium levels as described above.
It is important that you take your dose of Cinacalcet Abdi as advised by your doctor.
Other medicines and Cinacalcet Abdi
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines particularly etelcalcetide or any other medicines that lower the level of calcium in your blood.
You should not receive Cinacalcet Abdi together with etelcalcetide.
Tell your doctor if you are taking the following medicines.
Medicines such as these can affect how Cinacalcet Abdi works:
- medicines used to treat skin and fungal infections (ketoconazole, itraconazole and voriconazole);
- medicines used to treat bacterial infections (telithromycin, rifampicin and ciprofloxacin);
- a medicine used to treat HIV infection and AIDS (ritonavir);
- a medicine used to treat depression (fluvoxamine).
Cinacalcet Abdi may affect how medicines such as the following work:
- medicines used to treat depression (amitriptyline, desipramine, nortriptyline and clomipramine);
- a medicine used to relieve cough (dextromethorphan);
- medicines used to treat changes in heart rate (flecainide and propafenone);
- a medicine used to treat high blood pressure (metoprolol);
Cinacalcet Abdi with food and drink
Cinacalcet Abdi should be taken with or shortly after food.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Cinacalcet has not been tested in pregnant women. In case of pregnancy, your doctor may decide to modify your treatment, as cinacalcet might harm the unborn baby.
It is not known whether cinacalcet is excreted in human milk. Your doctor will discuss with you if you should discontinue either breast-feeding or treatment with Cinacalcet Abdi.
Driving and using machines
Dizziness and seizures have been reported by patients taking cinacalcet. If you experience these side effects, do not drive or operate machines.
Cinacalcet Abdi contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
3. How to take Cinacalcet Abdi
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Your doctor will tell you how much cinacalcet you must take.
Cinacalcet Abdi must be taken orally, with or shortly after food. The tablets must be taken whole and are not to be chewed, crushed or divided.
Cinacalcet is also available as granules for paediatric use. Children who require doses lower than 30 mg, or who are unable to swallow tablets should receive Cinacalcet granules .
Your doctor will take regular blood samples during treatment to monitor your progress and will adjust your dose if necessary.
If you are being treated for secondary hyperparathyroidism
The usual starting dose for Cinacalcet Abdi in adults is 30 mg (one tablet) once per day.
The usual starting dose of Cinacalcet Abdi for children aged 3 years to less than 18 years of age is no more than 0.20 mg/kg of body weight daily.
If you are being treated for parathyroid cancer or primary hyperparathyroidism
The usual starting dose for Cinacalcet Abdi is 30 mg (one tablet) twice per day.
If you take more Cinacalcet Abdi than you should
If you take more Cinacalcet Abdi than you should you must contact your doctor immediately. Possible signs of overdose include numbness or tingling around the mouth, muscle aches or cramps and seizures.
If you forget to take Cinacalcet Abdi
Do not take a double dose to make up for a forgotten dose.
If you have forgotten a dose of Cinacalcet Abdi, you should take your next dose as normal.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Please tell your doctor immediately:
- If you start to get numbness or tingling around the mouth, muscle aches or cramps and seizures. These may be signs that your calcium levels are too low (hypocalcaemia).
- If you experience swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing (angioedema).
Very common: may affect more than 1 in 10 people
- nausea and vomiting, these side effects are normally quite mild and do not last for long.
Common: may affect up to 1 in 10 people
- dizziness
- numbness or tingling sensation (paraesthesia)
- loss (anorexia) or decrease of appetite
- muscle pain (myalgia)
- weakness (asthenia)
- rash
- reduced testosterone levels
- high potassium levels in the blood (hyperkalaemia)
- allergic reactions (hypersensitivity)
- headache
- seizures (convulsions or fits)
- low blood pressure (hypotension)
- upper respiratory infection
- breathing difficulties (dyspnoea)
- cough
- indigestion (dyspepsia)
- diarrhoea
- abdominal pain, abdominal pain – upper
- constipation
- muscle spasms
- back pain
- low calcium levels in the blood (hypocalcaemia).
Not known: frequency cannot be estimated from available data
- Hives (urticaria)
- Swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing (angioedema).
- Unusually fast or pounding heart beat which may be associated with low levels of calcium in your blood (QT prolongation and ventricular arrhythmia secondary to hypocalcaemia).
After taking cinacalcet a very small number of patients with heart failure had worsening of their condition and/or low blood pressure (hypotension).
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system (see contact details below). By reporting side effects you can help provide more information on the safety of this medicine.
United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store
5. How to store Cinacalcet Abdi
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 and blister after EXP. The expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions.
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.
6. Contents of the pack and other information
What Cinacalcet Abdi contains
- The active substance is cinacalcet. Each film-coated tablet contains 30mg, 60mg or 90mg of cinacalcet (as hydrochloride).
- The other ingredients are lactose monohydrate, microcrystalline cellulose, pregelatinized starch, crospovidone, magnesium stearate and talc.
- The tablet coating contains hypromellose, titanium dioxide (E171), lactose monohydrate, triacetin, yellow iron oxide (E172) and indigo carmine lake (E132).
What Cinacalcet Abdi looks like and contents of the pack
Cinacalcet Abdi is a light green film-coated tablet. They are oval-shaped and have ‘C’ marked on one side and ‘30’, ‘60’ or ‘90’ on the other side.
Cinacalcet Abdi is available in blisters of 30 mg, 60 mg or 90 mg film-coated tablets. Each blister pack contains either 14, 28 or 84 tablets in a carton.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Abdi Farma GmbH
Donnersbergstraße 4
64646 Heppenheim
Germany
Manufacturer
S.C. Polisano Pharmaceuticals S.A., Alba Iulia Road 156, 550052 Sibiu, Sibiu County, Romania
Meditrial Internationals Ltd.,
Iztok Distr., 3 Charles Darwin Str.,
Sofia 1113,
Bulgaria
The medicinal product is authorized in the Member States of the EEA under the following names:
| Name of the Member State | Name of the medicinal product |
|---|---|
| Denmark | Cinacalcet Accord 30/60/90 mg filmovertrukne tabletter |
| Italy | Cinacalcet Abdi 30/60/90 mg compressa rivestita con film |
| Netherlands | Cinacalcet Accord 30/60/90 mg filmomhulde tabletten |
| Sweden | Cinacalcet Accord 30/60/90 mg filmdragerad tablet |
| United Kingdom | Cinacalcet Accord 30/60/90 mg film-coated tablets |
| Finland | Cinacalcet Accord 30/60/90 mg kalvopäällysteiset tabletit |
| Estonia | Cinacalcet Accord 30/60/90 mg õhukese polümeerikattega tabletid |
| Iceland | Cinacalcet Accord filmuhúðaðar töflur |
| Lithuania | Cinacalcet Accord plėvele dengtos tabletės |
| Latvia | Cinacalcet Accord apvalkotās tabletes |
| Norway | Cinacalcet Accord 30/60/90 mg filmdrasjerte tabletter |