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Adempas (Generic Riociguat)

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WARNING

If you are pregnant or intend to become pregnant, avoid using riociguat. The foetus may suffer from rociguat. If you are able to become pregnant and are sexually active, you should wait to start taking riociguat until a pregnancy test has revealed that you are not pregnant. Both during treatment and for one month after stopping riociguat, you must take effective birth control. Never engage in unprotected sex. Consult your doctor about effective birth control options that will suit your needs. If you miss a period while taking riociguat or believe you could be pregnant, call your doctor right away.

If you are the parent or legal guardian of a female who has not yet reached puberty, keep an eye out for any indicators of puberty in your kid (breast buds, pubic hair, etc.), and be sure to let her doctor know if anything changes. It’s possible for your youngster to hit puberty before experiencing her first period.

The only way to obtain riociguat is through a unique, restricted distribution programme due to the possibility of birth abnormalities. All female patients are required to participate in the Adempas Risk Evaluation and Mitigation Strategies (REMS) Program, which ensures that they are tested for pregnancy each month while undergoing therapy and for one month after stopping riociguat. Only female patients who have registered with the Adempas REMS Program are eligible to get riociguat. You will select the licenced specialty pharmacy that will send your prescription to you when you enrol. If you have any concerns about receiving your medication, speak with your doctor.

Whenever you need a prescription refill for riociguat, your doctor or pharmacist will provide you the manufacturer’s patient information leaflet (Medication Guide). If you have any questions, carefully read the material and contact your doctor or pharmacist. The Medication Guide is also available on the Food and Drug Administration (FDA) website.

Consult your doctor regarding the dangers of taking riciguat.

Why is this medication prescribed?

For the treatment of pulmonary arterial hypertension, utilise rociguat (PAH; high blood pressure in the vessels that carry blood to the lungs). Riociguat is also used to treat adults who cannot undergo surgery for chronic thromboembolic pulmonary hypertension (CTEPH; high blood pressure in the lung arteries brought on by blood clots that narrow or block blood flow) or for those who have undergone surgery but still have persistently high lung blood pressure levels. Riociguat may make it easier for persons with PAH and CTEPH to exercise, as well as slow the symptoms of PAH from getting worse. The drug ronociguat belongs to the group of drugs known as soluble guanylate cyclase (sGC) stimulators. In order to facilitate easy blood flow, it acts by relaxing the blood vessels in the lungs.

How should this medicine be used?

Riociguat is available as a tablet to be swallowed. Three times a day, it is typically taken with or without food. Take riociguat at about the same time(s) each day, and leave about 6 to 8 hours between doses. Ask your doctor or pharmacist to explain any instructions on your prescription label that you are unsure about following. RIOCIGUAT must be taken exactly as prescribed. Never take it in larger or less amounts or more frequently than directed by your doctor.

If you find it difficult to swallow the tablet whole, you can crush it and combine the contents with some water or a soft food, like applesauce. As soon as the liquid is combined, swallow it.

Your doctor might prescribe you a modest dose of riociguat and gradually increase it over the course of two weeks, at most. If you encounter side effects, your doctor might reduce your dose.

Other uses for this medicine

Ask your doctor or pharmacist for more details if you believe this drug should be used for something else.

What special precautions should I follow?

Before taking riociguat,

  • If you have an allergy to riociguat, any other drugs, or any of the ingredients in riociguat tablets, tell your doctor and pharmacist right away. For a list of the ingredients, consult the Medication Guide or speak with your pharmacist.
  • Inform your doctor if you take or have recently taken any nitrates, including nitroglycerin (Nitro-Dur, Nitromist, Nitrostat, Minitran, Rectiv, and others), isosorbide dinitrate (Isordil, in BiDil), isosorbide mononitrate (Monoket), and nitroglycerin; phosphodiesterase inhibitors (PDE-5) like avanafil (Stendra), or if you are taking theophylline or dipyridamole (Persantine, in Aggrenox) (Theo-24, Theochron, Theolair, others). If you are taking any of these drugs, your doctor will probably advise you not to take riociguat. Never use riociguat within 24 hours of taking sildenafil or within 48 hours of taking tadalafil, or within 24 hours of either.
  • Inform your doctor and pharmacist about any additional prescription and over-the-counter drugs, vitamins, dietary supplements, and herbal products you are now taking or intend to use. Incorporate any of the following: A number of antifungals, including itraconazole (Onmel, Sporanox) and ketoconazole (Extina, Nizoral, Xolegel); HIV protease inhibitors, such as ritonavir (Norvir, in Kaletra); a number of seizure drugs, including carbamazepine (Epitol, Equetro, Tegretol, and others); phenobarbital; and pheny Your physician might need to adjust the dosage of your drugs or keep a close eye on you for side effects.
  • Take them an hour before or an hour after taking riociguat if you’re taking antacids (Maalox, Mylanta, Tums, etc.) that include aluminium hydroxide or magnesium hydroxide.
  • Please let your doctor know if you are taking any herbal supplements, especially St. John’s wort.
  • If you have pulmonary hypertension and idiopathic interstitial pneumonia, let your doctor know (PH-IIP; lung disease). Most likely, your doctor will advise against using riciguat.
  • If you smoke now, start smoking during treatment, or stop smoking altogether, let your doctor know. Inform your doctor if you have recently experienced any lung bleeding, pulmonary veno-occlusive disease (a blockage of veins in the lungs), low blood pressure, heart, kidney, or liver disease, or if you have recently experienced diarrhoea, vomiting, or excessive sweating that may have resulted in dehydration (loss of a significant amount of body fluids).
  • Inform your doctor if you are nursing a child. While using riociguat, avoid breastfeeding.
  • You should be aware that riociguat can make you feel faint and woozy. Prior to understanding how this drug affects you, avoid using machinery or driving a car.

What special dietary instructions should I follow?

Keep eating normally unless your doctor instructs you otherwise.

What should I do if I forget a dose?

Ignore the missed dose and carry on with my normal dosing routine. Call your doctor if you miss taking Riociguat for more than three days. Your medicine might need to be restarted by your doctor at a reduced dose.

What side effects can this medication cause?

Riociguat could have negative effects. If any of these symptoms are severe or do not go away, let your doctor know right once:

  • Headache
  • Constipation
  • Heartburn
  • Uneasy stomach
  • Nausea
  • Vomiting
  • Diarrhea
  • Your hands, legs, feet, and ankles will swell

Some adverse effects can be very harmful. Call your doctor right away or seek emergency medical attention if you have any of these symptoms or any of those listed in the SPECIAL PRECAUTIONS section:

  • Coughing up blood or pink, foamy sputum
  • Fainting
  • Chest pain
  • Breathing difficulty

Other negative effects of ronociguat are possible. If you experience any strange issues while taking this medicine, contact your doctor right away.

You or your doctor can submit a report to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting programme online or by phone if you have a serious side event (1-800-332-1088).

What should I know about storage and disposal of this medication?

Keep this medication tightly closed in the original container and out of the reach of children. Store it away from excessive heat and moisture at room temperature (not in the bathroom).

Unused prescriptions must be disposed of carefully to prevent pets, kids, and other people from ingesting them. You should not, however, dispose of this medication in the toilet. Instead, utilising a medicine take-back programme is the easiest approach to get rid of your medication. To find out about take-back programmes in your area, speak with your pharmacist or the garbage/recycling department in your city. If you do not have access to a take-back programme, see the FDA’s Safe Disposal of Medicines website at http://goo.gl/c4Rm4p for additional information.

As many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and are simple for young children to open, it is crucial to keep all medications out of sight and out of reach of children. Always lock safety caps and promptly stash medication up and away from young children where it is out of their sight and reach to prevent poisoning. http://www.upandaway.org

In case of emergency/overdose

Call the poison control hotline at 1-800-222-1222 in the event of an overdose. Additionally, information can be found online at https://www.poisonhelp.org/help. Call 911 right once if the person has collapsed, experienced a seizure, is having difficulty breathing, or cannot be roused.

What other information should I know?

Keep all of your doctor’s appointments. Throughout the course of your riociguat medication, your doctor will frequently check your blood pressure.

No one else should take your medication.

You should keep a written record of every medication you take, including any over-the-counter (OTC) items, prescription drugs, and dietary supplements like vitamins and minerals. This list should be brought with you whenever you see a doctor or are admitted to the hospital. You should always have this information with you in case of emergencies.

Brand names

  • Adempas®
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