If you are the parent or caregiver of a female child who started taking Adempas before reaching puberty, you should check your child regularly to see if she is developing signs of puberty. Tell your doctor right away if you notice that she is developing breast buds or any pubic hair. Your doctor should decide if your child has reached puberty. Your child may reach puberty before having her first menstrual period.
Females can only receive Adempas through a restricted program called the Adempas Risk Evaluation and Mitigation Strategies (REMS) program. If you are a female who can become pregnant, you must talk to your doctor, understand the benefits and risks of Adempas, and agree to all of the instructions in the Adempas REMS program. Males can receive Adempas without taking part in the Adempas REMS program.
Ask your doctor or pharmacist if you are not sure if you take any of the medicines listed above.
Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.
Adempas and other medicines may affect each other causing side effects. Do not start any new medicine until you check with your doctor.
Tell your doctor if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of Adempas.
The Adempas clinical studies included mostly patients with WHO functional class II-III symptoms. It is unknown if Adempas is safe and effective in children.
For important risk and use information please see the full Prescribing Information , including Boxed Warning and Medication Guide .
You are encouraged to report side effects or quality complaints of products to the FDA by visiting www.fda.gov/medwatch or calling 1-800-FDA-1088. For Bayer products, you can report these directly to Bayer by clicking here.
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Site Last Modified: 10/2021