The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL 08553/0569 .
Cinacalcet Dr. Reddy's 90 mg Film-Coated Tablets
Cinacalcet 30 mg Film-Coated Tablets
Cinacalcet 60 mg Film-Coated Tablets
Cinacalcet 90 mg Film-Coated Tablets
1. What Cinacalcet is and what it is used for
2. What you need to know before you take Cinacalcet
3. How to take Cinacalcet
4. Possible side effects
5. How to store Cinacalcet
6. Contents of the pack and other information
Cinacalcet works by controlling the levels of parathyroid hormone (PTH), calcium and phosphorous 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 is used in adults:
Cinacalcet is used in children aged 3 years to less than 18 years of age:
In primary and secondary hyperparathyroidism too much PTH is produced by the parathyroid 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.
Do not take Cinacalcet if you are allergic to cinacalcet or any of the other ingredients of this medicine (listed in section 6).
Do not take Cinacalcet if you have low levels of calcium in your blood. Your doctor will monitor your blood calcium levels.
Talk to your doctor, pharmacist or nurse before taking cinacalcet.
Before you start taking cinacalcet, tell your doctor if you have or have ever had:
Cinacalcet 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.
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, tell your doctor:
Children under the age of 18 with parathyroid cancer or primary hyperparathyroidism must not take cinacalcet.
If you are being treated for secondary hyperparathyroidism, your doctor should monitor your calcium levels before starting treatment with cinacalcet and during treatment with cinacalcet. 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 as advised by your doctor.
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 together with etelcalcetide.
Tell your doctor if you are taking the following medicines. Medicines such as these can affect how cinacalcet works:
Cinacalcet may affect how medicines such as the following work:
Cinacalcet should be taken with or shortly after food.
If you are pregnant or breastfeeding, 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.
Dizziness and seizures have been reported by patients taking cinacalcet. If you experience these side effects, do not drive or operate machines.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are unsure. Your doctor will tell you how much Cinacalcet you must take.
Cinacalcet 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 in capsules for opening. 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.
The usual starting dose for cinacalcet in adults is 30 mg (one tablet) once per day.
The usual starting dose of cinacalcet for children aged 3 years to less than 18 years of age is no more than 0.20 mg/kg of body weight daily.
The usual starting dose for cinacalcet in adults is 30 mg (one tablet) twice per day.
If you take more Cinacalcet 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.
Do not take a double dose to make up for a forgotten dose. If you have forgotten a dose of Cinacalcet, 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.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Very common: may affect more than 1 in 10 people
Common: may affect up to 1 in 10 people
Not known: frequency cannot be estimated from available data
After taking cinacalcet a very small number of patients with heart failure had worsening of their condition and/or low blood pressure (hypotension).
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 Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
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.
Cinacalcet tablets are light green film-coated tablets. They are oval-shaped and have “30”, “60” or “90” marked on one side and “C” on the other side.
Cinacalcet is available in blisters of 30 mg, 60 mg or 90 mg film-coated tablets. Each blister pack contains either 14, 28, 42, 84 or 98 film-coated tablets in a carton.
Not all pack sizes may be marketed.
This leaflet was last revised in 06/2022