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Additional, less frequent adverse reactions ( 6%) reported in the controlled clinical trials of Cialis for BPH or ED and BPH included: gastroesophageal reflux disease, upper abdominal pain, nausea, vomiting, arthralgia, and muscle spasm.

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Due to increased tadalafil exposure (AUC), limited clinical experience, and the lack of ability to influence clearance by dialysis, Cialis for once daily use is not recommended in patients with creatinine clearance less than 85 mL/min. In patients with creatinine clearance 85 &ndash 55 mL/min, start dosing at mg once daily, and increase the dose to 5 mg once daily based upon individual response [see Dosage and Administration ( ), Use in Specific Populations ( ), and Clinical Pharmacology ( )].

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Medicines are sometimes prescribed for conditions other than those described in patient information leaflets. Do not use Cialis for a condition for which it was not prescribed. Do not give Cialis to other people, even if they have the same symptoms that you have. It may harm them.

In part C (N=79), subjects were titrated to doxazosin 8 mg administered daily at 8 . In this part, tadalafil or placebo were administered at either 8 . or 8 .

Read this important information before you start taking Cialis and each time you get a refill. There may be new information. You may also find it helpful to share this information with your partner. This information does not take the place of talking with your healthcare provider. You and your healthcare provider should talk about Cialis when you start taking it and at regular checkups. If you do not understand the information, or have questions, talk with your healthcare provider or pharmacist.

ED and symptoms of BPH may happen in the same person and at the same time. Men who have both ED and symptoms of BPH may take Cialis for the treatment of both conditions.

There is no information on the presence of tadalafil and/or metabolites in human milk, the effects on the breastfed child, or the effects on milk production. Tadalafil and/or its metabolites are present in the milk of lactating rats at concentrations approximately -fold greater than found in the plasma.

The efficacy results for patients with both ED and BPH, who received either Cialis 5 mg for once daily use or placebo (N=958) are shown in Tables 76 and 77 and Figure 8.

When taken as recommended in the placebo-controlled clinical trials, the following adverse reactions were reported ( see Table 6 ) for Cialis for use as needed:

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