Palsonify – Package Leaflet: InfoCons – Consumer Protection presents, in an accessible format, the official package leaflet of the medicine Palsonify, as authorised in the European Union and published in the Union Register of medicinal products.
Before anything else
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor, or pharmacist or nurse.
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
- If you get any side effects, talk to your doctor, or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
ℹ️ 1. What Palsonify is and what it is used for
Palsonify contains the active substance paltusotine. It works by targeting a receptor for a natural hormone in your body called somatostatin, which acts by reducing the growth hormone production by the pituitary tumour .
Palsonify is used in adults for the treatment of acromegaly.
Acromegaly is a rare condition. Most often, it’s caused by a noncancerous tumour in a small gland in the brain (called the pituitary gland). This tumour causes the gland to release too much growth hormone (GH). This extra GH leads to symptoms such as enlar ged hands or feet, headache, excessive sweating, numbness in the hands and feet, tiredness and joint pain.
The active substance in Pal sonify, paltusotine, blocks the release of growth hormone by the pituitary gland by attaching to somatostatin receptors (targets). This is expected to improve symptoms of acromegaly.
⚠️ 2. What you need to know before you take Palsonify
Do not take Palsonify
- i f you are allergic to paltusotine or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions Talk to your doctor, pharmacist or nurse before taking Palsonify , or during treatment if you have:
33 * Heart problems: Palsonify can affect the rate of your heartbeat (see section 2 Other medicines and Palsonify) .
- Gallbladder problems: Palsonify can cause gallstones to form (with sudden pain in the upper right area of your belly (abdomen), sudden pain in your right shoulder or between your shoulder blades, yellowing of your skin or the whites of your eyes, or pale stools) .
- Diabetes: Palsonify may affect your blood sugar. Increased blood sugar levels may occur. Therefore, your doctor may recommend monitoring blood sugar levels and treatment of diabetes (see section 2 Other medicines and Palsonify ).
- Ever had lack of vitamin B12: Medicines that target somatostatin receptor can decrease vitamin B12 levels in the blood, your doctor may wish to check your vitamin B12 level periodically during treatment with Palsonify.
Monitoring during treatment Tumours of the pituitary gland that produce excess growth hormone and lead to acromegaly sometimes expand, causing serious complications such as problems with eyesight . Your doctor will monitor you for signs and symptoms of tumour growth while you are receiving treatment with Palsonify . If evidence of tumour expansion appears, your doctor may prescribe a different treatment.
Your doctor will regularly check your thyroid function during treatment .
Children and adolescents
Do not give this medicine to children and adolescents under 18 years . It is not known if it is safe or effective in this age group .
Other medicines and Palsonify
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Tell your doctor if you are taking any of the following medicines, since their activity or side effects may change when used together with Palsonify . If you take these medicines, your doctor may need to adjust the doses of these medicines:
- medicines called beta blockers (e.g. atenolol, metoprolol , carvedilol , nebivolol ), and cardiac glycosides (e.g. digoxin) used to treat high blood pressure or heart diseases
- fluoxetine (an antidepressant )
- dextromethorphan (a cough suppressant)
- tacrolimus (a medicine to suppress transplant rejectio n)
- insulin or other medicines to treat diabetes Tell your doctor if you are taking the following medicines as they may reduce the effectiveness of Palsonify by reducing the amount of Palsonify in the blood :
- carbamazepine and phenytoin (used to treat seizures and epilepsy)
- apalutamide (used to treat prostate cancer)
- efavirenz ( used to treat HIV)
- prednisone (used to help suppress the body’s immune system )
- lansoprazole and similar medicines (used to control or reduce stomach acid) Tell your doctor if you are taking the following medicine as Pal sonify may reduce the effectiveness of this medicine . If you take this medicine, your doctor may need to adjust the doses of this medicine :
- cyclosporine (a medicine to suppress transplant rejection, treat severe skin diseases, severe eye and joint inflammation) If you are not sure if the above applies to you, ask your doctor or pharmacist.
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.
You should not use Palsonify if you are pregnant.
It is not known whether Palsonify passes into breast milk. Do not breast-feed while using Palsonify .
Women who can become pregnant should use effective contraception (birth control) during treatment with Palsonify .
Driving and using machines
Palsonify has no or negligible influence on the ability to drive and use machines.
💊 3. H ow to take Palsonify
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Palsonify is available as film -coated tablets taken by mouth. If it is the first time you are taking medicine for acromegaly, the recommended starting dose is 20 mg taken once daily. If it is not the first time that you take medicine for acromegaly, the recommended starting dose is 40 mg taken once daily.
Your doctor will check your symptoms and the level of a substance called insulin -like growth factor after at least 2 to 4 week s of treatment to check how you are responding. If necessary, your doctor may increase your dose up to 60 mg taken once daily.
Your doctor may temporarily reduce the dose by 20 mg based on how well you tolerate treatment.
Your doctor may temporarily increase the dose of paltusotine due to administration with other medicinal products (see section 2 Other medicines and Palsonify).
Swallow the tablets whole with a glass of water, on an empty stomach , at least 6 hours after a meal (e.g. after overnight fast), and at least 1 hour before your next meal.
If you take more Palsonify than you should
If you have taken more Palsonify than you should, stop taking the medicine and contact your doctor or pharmacist immediately.
If you forget to take Palsonify
Do not take a double dose to make up for a forgotten dose. S kip the missed dose and then take the next dose as usual on the next day .
If you stop taking Palsonify
Do not stop taking this medicine without discussing with your doctor first.
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.
Contact your doctor if you experience any side effects. Your doctor may pause treatment with Palsonify until your symptoms improve and/or they may reduce the dose you receive.
Very c ommon (may affect more than 1 in 10 people)
- Diarrhoea
Common (may affect up to 1 in 10 people)
- High blood glucose levels (hyperglycaemia)
- Decreased appetite
- Headache 35 • Slow heart rate (sinus bradycardia)
- Belly (a bdominal) pain
- Feeling sick (nausea)
- Abdominal discomfort
- Swelling of your belly (abdominal distension)
- Vomiting
- Gallstones (cholelithiasis)
- Hair loss (a lopecia)
- Fatigue
Uncommon (may affect up to 1 in 100 people)
- Gallstones in the bile duct ( bile duct stone)
- Dizziness
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 listed in Appendix V . By reporting side effects, you can help provide more information on the safety of this medicine.
🌡️ 5. How to store Palsonify
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 bottle after “ EXP ”.
The expiry date refers to the last day of that month.
No 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 Palsonify contains
- The active substance is paltusotine (as paltusotine hydrochloride).
Palsonify 20 mg film-coated tablets contain 20 mg of paltusotine .
Palsonify 30 mg film-coated tablets contain 30 mg of paltusotine .
- The other ingredients are:
Tablet core : copovidone, microcrystalline cellulose, crospovidone, anhydrous colloidal silica, magnesium stearate, mannitol (E 421).
Film -coating:
Palsonify 20 mg film -coated tablets : Hypromellose , titanium dioxide (E 171) , triacetin (E 1518), yellow iron oxide (E 172), red iron oxide (E 172).
Palsonify 30 mg film -coated tablets : Hypromellose , titanium dioxide (E 171), triacetin (E 1518), yellow iron oxide (E 172).
What Palsonify looks like and contents of the pack
Palsonify 20 mg film-coated tablets are p ink, biconvex oval film -coated tablet s, 16 mm length and 8 mm width , debossed with “PAL” on one side and “20” on the other side.
Palsonify 30 mg film-coated tablets are y ellow, biconvex oval film- coated tablet s, 18 mm length and 9 mm width , debossed with “PAL” on one side and “30” on the other side.
36 Palsonify 20 mg and 30 mg film- coated tablets are available in plastic bottles , secured with child – resistant closure and heat induction sealed.
Each bottle contains 60 film-coated tablets and a silica gel desiccant .
Each carton contains one bottle.
Marketing Authorisation Holder
Crinetics Pharmaceuticals Europe GmbH Barbara Strozzilaan 201 1083HN Amsterdam Netherland s
Manufacturer
Cilatus Manufacturing Services Limited Pembroke House 28-32 Pembroke Street Upper Dublin 2 Co. Dublin D02 EK84 Ireland
This leaflet was last revised in
Other sources of information Detailed information on this medicine is available on the European Medicines Agency web site: https://www.ema.europa.eu There are also links to other websites about rare diseases and treatments.
This leaflet is available in all EU/EEA languages on the European Medicines Agency website.
📄 Package Leaflet – official source
This article reproduces the information in the official package leaflet, as authorised in the European Union. You can consult the original document here: Product information Palsonify (PDF, ec.europa.eu).
You can check this medicine at any time in the Union Register of medicinal products (EU number EU/1/26/2021).
⚠️ Important: This article is for information purposes only and does not replace medical advice or the package leaflet inside the medicine box. Read the leaflet carefully before use. For any questions about your treatment, talk to your doctor or pharmacist. If you experience side effects, tell your doctor or pharmacist and report them through your national reporting system.